ClearanceBrief
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)
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Top companies in JWY

DateFirm and productCodeLinked 510(k)
Jun 11, 2025Remel, Inc
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Open, Classified
JWYK111429
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788
Open, Classified
JWYK980348
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786
Open, Classified
JWYK010363
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
Open, Classified
JWYK181031
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553
Open, Classified
JWYK192050
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
Open, Classified
JWYK191953
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046
Open, Classified
JWYK172150
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445
Open, Classified
JWYK170670
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
Open, Classified
JWYK980348
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
Open, Classified
JWYK102668
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
Open, Classified
JWYK982868
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
Open, Classified
JWYK990297
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
Open, Classified
JWYK010363
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392
Open, Classified
JWYK971697
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
Open, Classified
JWYK960989
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
Open, Classified
JWYK913459
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331
Open, Classified
JWYK020748
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302
Open, Classified
JWYK981139
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262
Open, Classified
JWYK981135
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252
Open, Classified
JWYK913459
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
Open, Classified
JWYK950328
Jan 4, 2023Biomerieux Inc
ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218
Open, Classified
JWYK970210
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Dec 8, 2022Remel Inc
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
Terminated
JWYK060621
K073424 +4
Jan 10, 2022Remel Inc
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Terminated
JWYK193538
Jun 24, 2021Biomerieux Inc
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Terminated
JWYK191953
Oct 2, 2018Beckman 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
JWYNone listed
Dec 19, 2017BioMerieux SA
ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Terminated
JWYK913459
Dec 19, 2017BioMerieux SA
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Terminated
JWYK913459
May 3, 2017BioMerieux 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
JWYK945433
May 3, 2017BioMerieux 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
JWYK020748
Mar 21, 2017BioMerieux 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
JWYK980345
Mar 21, 2017BioMerieux 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
JWYK102668
Mar 21, 2017BioMerieux 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
JWYK913459
Mar 21, 2017BioMerieux 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
JWYK960989
Mar 21, 2017BioMerieux 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
JWYK981136
Mar 21, 2017BioMerieux 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
JWYK981135
Mar 21, 2017BioMerieux 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
JWYK081325
Mar 21, 2017BioMerieux 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
JWYK980348
Mar 21, 2017BioMerieux 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
JWYK981138
Mar 21, 2017BioMerieux 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
JWYK980345
Mar 21, 2017BioMerieux 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
JWYK913459
Mar 21, 2017BioMerieux 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
JWYK971694

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