Company ยท US
Oxoid U.S.A., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2007. Name variants (Inc, Corp, punctuation) are merged.
129510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 33 |
| JSK | Supplement, Culture Media | 30 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 11 |
| JSJ | Culture Media, Selective And Non-Differential | 10 |
| JSI | Culture Media, Selective And Differential | 7 |
| JSG | Culture Media, Non-Selective And Non-Differential | 5 |
| GMQ | Antigens, Nontreponemal, All | 3 |
| GNA | Antisera, All Types, Escherichia Coli | 3 |
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | 2 |
| KZJ | Device, Gas Generating | 2 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| FRC | Indicator, Biological Sterilization Process | 1 |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| IBG | Trypsin | 1 |
| JSC | Culture Media, General Nutrient Broth | 1 |
| JSD | Culture Media, Selective Broth | 1 |
| JSF | Culture Media, Single Biochemical Test | 1 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 1 |
| JSP | Kit, Anaerobic Identification | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2007 | K070262 | ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Mar 17, 2006 | K060286 | TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 14, 2004 | K042157 | DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Apr 2, 2002 | K011710 | OXOID PBP2 1 LATEX AGGLUTINATION TEST Oxoid , Ltd., GB | MYI |
| Dec 10, 2001 | K012588 | OXOID PYLORI TEST KIT, MODEL DR0130M Oxoid , Ltd., GB | LYR |
| Apr 24, 2001 | K010537 | LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Apr 24, 2001 | K010536 | MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| May 22, 2000 | K000930 | GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| May 15, 2000 | K000928 | QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Feb 28, 2000 | K993401 | DRYSPOT E.COLI 0157 KIT Oxoid , Ltd., GB | GNA |
| Apr 2, 1999 | K984513 | TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Mar 9, 1999 | K984608 | GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Jan 28, 1999 | K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT Oxoid , Ltd., GB | KTN |
| Jan 13, 1999 | K984036 | NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Dec 11, 1998 | K983718 | MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982669 | OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982528 | NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982526 | SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982524 | AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982523 | SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982520 | CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982519 | LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 9, 1998 | K982517 | CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Jan 28, 1998 | K971636 | RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Jan 14, 1998 | K974394 | ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Dec 23, 1997 | K971637 | COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Dec 1, 1997 | K973479 | CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Oct 10, 1997 | K973489 | LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Oct 10, 1997 | K973488 | LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Oct 6, 1997 | K973487 | CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Sep 8, 1997 | K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS Oxoid , Ltd., GB | JWX |
| Aug 20, 1997 | K971638 | CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Aug 13, 1997 | K971632 | TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Jul 3, 1997 | K971635 | AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Jul 3, 1997 | K971633 | PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Jul 3, 1997 | K971631 | CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC Oxoid , Ltd., GB | JTN |
| Jun 9, 1989 | K891593 | LISTERIA SELECTIVE ENRICHMENT MEDIUM Oxoid U.S.A., Inc. | JSI |
| Feb 3, 1989 | K884026 | ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT Oxoid U.S.A., Inc. | GNA |
| Oct 25, 1988 | K884208 | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) Oxoid U.S.A., Inc. | KZI |
| Nov 6, 1987 | K874303 | STAPHYLASE TEST Oxoid U.S.A., Inc. | LHT |
| Aug 10, 1987 | K872956 | SORBITOL MACCONKEY AGAR NO. 3 CM 813 Oxoid U.S.A., Inc. | JSI |
| Jun 15, 1987 | K872135 | MCBRIDE MEDIUM CM 819 Oxoid U.S.A., Inc. | JSJ |
| Jun 10, 1987 | K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 Oxoid U.S.A., Inc. | JTL |
| Nov 5, 1986 | K862946 | OXOID SIGNAL BLOOD CULTURE SYSTEM Oxoid U.S.A., Inc., GB | JSG |
| Nov 4, 1986 | K855236 | DIAGNOSTIC REAGENT TST-RPLA Oxoid U.S.A., Inc. | GTN |
| Nov 4, 1986 | K855235 | DIAGNOSTIC REAGENT PET-RPLA Oxoid U.S.A., Inc. | JSP |
| Nov 4, 1986 | K855234 | DIAGNOSTIC REAGENT VET-RPLA Oxoid U.S.A., Inc. | GNA |
| Nov 4, 1986 | K855233 | DIAGNOSTIC REAGENT SET-RPLA Oxoid U.S.A., Inc. | GTN |
| Mar 11, 1986 | K854929 | OXOID STREPTOCOCAL GROUPING KIT Oxoid U.S.A., Inc. | GTZ |
| Mar 4, 1986 | K860153 | OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS Oxoid U.S.A., Inc., GB | JTN |
Newest 50 of 129.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2025 | Oxoid Limited Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 Open, Classified |
JTN | K060286 |