Company ยท US
Remel Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2017. Name variants (Inc, Corp, punctuation) are merged.
164510(k) clearances (0 in 12 months)
113recalls (4 in 12 months)
57recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 51 |
| JTN | Susceptibility Test Discs, Antimicrobial | 30 |
| JSG | Culture Media, Non-Selective And Non-Differential | 19 |
| JSI | Culture Media, Selective And Differential | 16 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 13 |
| JTS | Stains, Microbiologic | 13 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 13 |
| JSJ | Culture Media, Selective And Non-Differential | 12 |
| JSM | Culture Media, Non-Propagating Transport | 7 |
| JSK | Supplement, Culture Media | 6 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 6 |
| LIO | Device, Specimen Collection | 6 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 5 |
| MHI | Giardia Spp. | 5 |
| JSF | Culture Media, Single Biochemical Test | 4 |
| JWX | Kit, Screening, Staphylococcus Aureus | 4 |
| JXB | Kit, Identification, Yeast | 4 |
| LLH | Reagents, Clostridium Difficile Toxin | 4 |
| JSH | Culture Media, Non-Selective And Differential | 3 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2017 | K162620 | Remel Spectra ESBL Remel, Inc. | JSO |
| Jul 12, 2013 | K131804 | REMEL XPECT FLU A&B Remel, Inc. | GNX |
| Oct 8, 2010 | K092407 | REMEL SPECTRA MRSA Remel, Inc. | JSO |
| Nov 26, 2007 | K072827 | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE Remel, Inc. | MJE |
| Nov 15, 2004 | K041951 | XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B Remel, Inc. | LLH |
| Feb 26, 2004 | K033479 | PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY Remel, Inc. | LLH |
| Nov 18, 2003 | K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 Remel, Inc. | MHI |
| Nov 14, 2003 | K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 Remel, Inc. | MHJ |
| Nov 10, 2003 | K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY Remel, Inc. | MHI |
| Jul 17, 2003 | K031565 | XPECT INFLUENZA A/B Remel, Inc. | PSZ |
| Nov 26, 2001 | K013711 | BACTI-SWAB DRY Remel Co. | LIO |
| Jul 14, 1998 | K981391 | PAR-ONE Remel, Inc. | LIO |
| Aug 28, 1997 | K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN Remel, L.P. | JSO |
| Apr 24, 1997 | K970832 | PYR SWAB Remel, Inc. | JTO |
| Apr 17, 1997 | K970834 | GRAM SWAB Remel, Inc. | JTO |
| Apr 2, 1997 | K970833 | INDOLE SWAB Remel, Inc. | JTO |
| Apr 2, 1997 | K970831 | REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK Remel, Inc. | JTN |
| Apr 2, 1997 | K970830 | REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK Remel, Inc. | JTN |
| Feb 7, 1997 | K964315 | REMEL STAPH LATEX KIT Remel, L.P. | JWX |
| Jan 22, 1997 | K965152 | A.C.T. II Remel Co. | JSM |
| Jan 22, 1997 | K965151 | A.C.T. III Remel Co. | JSM |
| Jan 22, 1997 | K965150 | A.C.T. IV Remel Co. | JSM |
| Jan 22, 1997 | K965149 | A.C.T. I Remel Co. | JSM |
| Dec 6, 1996 | K964421 | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK Remel, L.P. | JTN |
| Sep 18, 1996 | K961046 | 10B ARGININE BROTH Remel, L.P. | JSM |
| Jul 30, 1996 | K955143 | RPR LIQUID CONTROLS Remel, L.P. | GMP |
| Jul 29, 1996 | K955136 | RPR CARD TEST KIT Remel, L.P. | GMQ |
| Jul 10, 1996 | K961819 | STREPTOMYCIN DISK (300MCG) Remel, L.P. | JTN |
| Jul 10, 1996 | K961818 | GENTAMICIN DISK (120MCG) Remel, L.P. | JTN |
| Mar 25, 1996 | K960313 | MUELLER HINTON AGAR WITH 2% NACI Remel, L.P. | JTZ |
| Mar 19, 1996 | K960095 | BACTIDROP CALCOFLUOR WHITE Remel Co. | JTS |
| Mar 19, 1996 | K960090 | CALCOFLUOR WHITE STAIN KIT Remel Co. | JTS |
| Feb 23, 1996 | K955669 | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK Remel Co. | JTN |
| Feb 16, 1996 | K954986 | GC BASE W/ 1% GCHI Remel, L.P. | JTY |
| Sep 19, 1994 | K941444 | BHI AGAR WITH VANCOMYCIN Remel Co. | JSO |
| Sep 19, 1994 | K941443 | SYNERGY QUAD Remel Co. | JSO |
| Sep 19, 1994 | K935975 | REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG Remel, Inc. | JTN |
| May 20, 1994 | K936021 | BACTICARD STREP Remel Co. | JTO |
| Apr 20, 1994 | K933457 | RIM E.COLI 0157:H7 LATEX TEST Remel Co. | GNA |
| Feb 25, 1994 | K935124 | BACTICARD CANDIDA Remel Co. | JXB |
| Feb 23, 1994 | K934986 | BACTICARD E. COLI Remel Co. | JTO |
| Nov 22, 1993 | K934100 | REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK Remel Co. | JTN |
| Oct 28, 1993 | K933657 | REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK Remel Co. | JTN |
| Oct 28, 1993 | K933514 | BACTICARD STREP Remel Co. | JTO |
| Aug 10, 1993 | K933118 | REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK Remel Co. | JTN |
| Jun 15, 1993 | K931799 | REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK Remel Co. | JTN |
| Jun 15, 1993 | K931383 | ZINC PVA Remel Co. | LIO |
| Jun 2, 1993 | K931289 | REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK Remel Co. | JTN |
| May 20, 1993 | K931290 | REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK Remel Co. | JTN |
| May 11, 1993 | K930878 | BACTIDROP(TM) MUCAP Remel Co. | JTO |
Newest 50 of 164.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2026 | Remel, Inc GC Agar Base (150mm) 10/PK R04030;
GC Agar Base (100mm) 10/PK R01460 Open, Classified |
JTY | K954986 |
| Apr 10, 2026 | Remel, Inc Yeastone Broth, 11ML, 10/BOX
YY3462 Open, Classified |
NGZ | K090968 |
| Feb 26, 2026 | Remel, Inc Campy CVA Medium 100/PK, R01272 Open, Classified |
JSJ | None listed |
| Nov 21, 2025 | Remel, Inc 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10
2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 Open, Classified |
JTZ | K790687 K802957 |
| Jul 31, 2025 | Remel, Inc Blood/MacConkey Biplate 100/PK, Product Number R02049 Open, Classified |
JSI | None listed |
| Jul 31, 2025 | Remel, Inc Blood/EMB, Levine 100/PK, Product Number R02041 Open, Classified |
JSI | None listed |
| Jul 31, 2025 | Remel, Inc Strep Selective II Agar, Product Number R01859 Open, Classified |
JSI | K843193 |
| Jul 31, 2025 | Remel, Inc Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 Open, Classified |
JSH | None listed |
| Jun 11, 2025 | Remel, Inc Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device Open, Classified |
JWY | K111429 |
| Mar 19, 2025 | Remel, Inc Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ Open, Classified |
LRG | K191918 |
| Feb 20, 2025 | Remel, Inc remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use Open, Classified |
JSI | None listed |
| Feb 20, 2025 | Remel, Inc remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use Open, Classified |
JSI | None listed |
| Oct 30, 2024 | Remel, Inc remel BactiDrop Acridine Orange, REF 21502, 50 per package. Open, Classified |
JFO | K920974 |
| Sep 8, 2023 | Remel, Inc remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora Open, Classified |
JSD | K871447 |
| Jun 29, 2023 | Remel, Inc Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use. Open, Classified |
JSO | K892928 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Dec 8, 2022 | Remel Inc Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST Terminated |
JWY | K060621 K073424 +4 |
| Jan 10, 2022 | Remel Inc Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format Terminated |
JWY | K193538 |
| Jun 18, 2021 | Remel Inc ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom Terminated |
JTN | K982524 |
| Apr 22, 2021 | Remel Inc Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identificat Terminated |
JSO | K972359 |
| Mar 10, 2021 | Remel Inc Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503
Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards I Open, Classified |
JSO | K892928 |
| Mar 10, 2021 | Remel Inc Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033
Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards In Open, Classified |
JSO | K892928 |
| Dec 10, 2020 | Remel Inc Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049 Terminated |
JSI | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/o Ind, w/Dex (18ml) 20/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/o Ind, w/Dex (18ml) 100/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hem, Vit K(10ml) 100/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hem, Vit K (10ml) 20/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/o Ind, w/Dex (10ml) 100/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/o Ind, w/Dex (10ml) 20/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hem, Vit K (9ml) 20/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/o Ind, w/Dex (9ml) 20/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hem, Vit K (9ml) 100/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/o Ind, w/Dex (9ml) 100/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK
Product Usage;
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hem, Vit K (7ml) 20/PK
Product Usage;
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK
Product Usage:
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Apr 17, 2019 | Remel Inc Thio Med w/Dex, Hem, Vit K (5ml) 100/PK
Product Usage;
Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes Terminated |
JSG | None listed |
| Jan 4, 2019 | Remel Inc. SWIN 2017 database, Model YSW4000 Terminated |
LON | None listed |
| Aug 13, 2018 | Remel Inc remel THIOGLYCOLLATE MEDIUM, REF 05152 Terminated |
JSG | None listed |
| Aug 13, 2018 | Remel Inc remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE
(a) 9ML, REF 064700
(b) 10ML, REF 07176
(c) 9ML, REF 064702 Terminated |
JSG | None listed |
| Aug 13, 2018 | Remel Inc remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K
(a) 10ML, REF 07182
(b) 10ML, REF 07180
(c) 5ML, REF 064732
(d) 5ML, REF 064730
(e) 9ML, REF 064720 Terminated |
JSG | None listed |
| Dec 8, 2017 | Remel Inc Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01.
Product Usage:
Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiol Terminated |
GNB | None listed |
| Nov 2, 2017 | Remel Inc CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. Terminated |
JTZ | K802498 |
Newest 50 of 113.