Panels › Microbiology › Product code JWY · Class 2
Manual Antimicrobial Susceptibility Test Systems
Regulation 866.1640
2510(k)s in 12 months (441 all time)
0recalls in 12 months (78 all time)
77recalls that name a 510(k)
Top companies in JWY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788 Open, Classified |
JWY | K980348 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 Open, Classified |
JWY | K010363 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 Open, Classified |
JWY | K181031 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 Open, Classified |
JWY | K192050 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 Open, Classified |
JWY | K191953 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046 Open, Classified |
JWY | K172150 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 Open, Classified |
JWY | K170670 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486 Open, Classified |
JWY | K980348 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478 Open, Classified |
JWY | K102668 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449 Open, Classified |
JWY | K982868 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407 Open, Classified |
JWY | K990297 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 Open, Classified |
JWY | K010363 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392 Open, Classified |
JWY | K971697 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 Open, Classified |
JWY | K960989 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333 Open, Classified |
JWY | K913459 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331 Open, Classified |
JWY | K020748 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302 Open, Classified |
JWY | K981139 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262 Open, Classified |
JWY | K981135 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 Open, Classified |
JWY | K913459 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240 Open, Classified |
JWY | K950328 |
| Jan 4, 2023 | Biomerieux Inc ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 Open, Classified |
JWY | K970210 |
| 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 24, 2021 | Biomerieux Inc ETEST IMIPENEM RELEBACTAM. in vitro diagnostic Terminated |
JWY | K191953 |
| Oct 2, 2018 | Beckman Coulter Inc. BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015
MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for in Terminated |
JWY | None listed |
| Dec 19, 2017 | BioMerieux SA ETEST OXACILLIN OX 256 WW F100
In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species. Terminated |
JWY | K913459 |
| Dec 19, 2017 | BioMerieux SA ETEST OXACILLIN OX 256 US F100
In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species. Terminated |
JWY | K913459 |
| May 3, 2017 | BioMerieux SA Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive Terminated |
JWY | K945433 |
| May 3, 2017 | BioMerieux SA ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria
( Terminated |
JWY | K020748 |
| Mar 21, 2017 | BioMerieux SA ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-p Terminated |
JWY | K980345 |
| Mar 21, 2017 | BioMerieux SA ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-po Terminated |
JWY | K102668 |
| Mar 21, 2017 | BioMerieux SA ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-po Terminated |
JWY | K913459 |
| Mar 21, 2017 | BioMerieux SA ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aero Terminated |
JWY | K960989 |
| Mar 21, 2017 | BioMerieux SA ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-po Terminated |
JWY | K981136 |
| Mar 21, 2017 | BioMerieux SA ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negat Terminated |
JWY | K981135 |
| Mar 21, 2017 | BioMerieux SA ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive Terminated |
JWY | K081325 |
| Mar 21, 2017 | BioMerieux SA ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positi Terminated |
JWY | K980348 |
| Mar 21, 2017 | BioMerieux SA Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive Terminated |
JWY | K981138 |
| Mar 21, 2017 | BioMerieux SA ETEST Ceftriaxone TXL32 SPB, Product Name: ETEST Ceftriaxone TX 0.002-32(low).
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aer Terminated |
JWY | K980345 |
| Mar 21, 2017 | BioMerieux SA ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-posit Terminated |
JWY | K913459 |
| Mar 21, 2017 | BioMerieux SA ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256.
ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-posit Terminated |
JWY | K971694 |
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