ENTEROCOCCUS SCREENING MEDIUM— 510(k) K951539
Substantially EquivalentBecton Dickinson Microbiology Systems
FDA 510(k) clearance K951539 for ENTEROCOCCUS SCREENING MEDIUM, Substantially Equivalent on 1995-06-13. Applicant: Becton Dickinson Microbiology Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Microbiology Systems
- 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
- Cockeysville, MD, US
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 Becton Dickinson Microbiology Systems
view all- K993577 — CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
- K984631 — BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
- K981517 — CEFDINIR, 5 UG, SENSI-DISC
- K980683 — TROVAFLOXACIN 10G, SENSI-DISC
- K974578 — GREPAFLOXACIN, 5 MG, SENSI-DISC
Recalls naming K951539
K-number listed on FDA's recall record- Z-0473-2016 — Vancomycin Screen Agar
- Z-0474-2016 — Enterococcus Screen Agar QUAD Plate
- Z-2628-2014 — BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
- Z-1798-2013 — BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951539.
Data sourced from openFDA. This site is unofficial and independent of the FDA.