ETEST SUBMISSION FOR IMIPENEM— 510(k) K960989
Substantially EquivalentAb Biodisk
FDA 510(k) clearance K960989 for ETEST SUBMISSION FOR IMIPENEM, Substantially Equivalent on 1996-05-20. Applicant: Ab Biodisk. Device class: 2.
Clearance details
- Applicant
- Ab Biodisk
- Product code
- Code JWY
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solna, SE
Recent devices under product code JWY
view all- K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- K260696 — MTS Gepotidacin 0.016-256 µg/mL
- K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
- K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
More clearances from Ab Biodisk
view all- K081325 — ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
- K052366 — ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
- K042392 — DAPTOMYCIN
- K042390 — ETEST FOR GEMIFLOXACIN
- K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
Recalls naming K960989
K-number listed on FDA's recall record- Z-0825-2023 — ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373
- Z-1529-2017 — 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 aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960989.
Data sourced from openFDA. This site is unofficial and independent of the FDA.