AMOXICILLIN/CLAVULANIC ACID 2/1— 510(k) K950328
Substantially EquivalentAb Biodisk North America, Inc.
FDA 510(k) clearance K950328 for AMOXICILLIN/CLAVULANIC ACID 2/1, Substantially Equivalent on 1995-04-14. Applicant: Ab Biodisk North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Ab Biodisk North America, Inc.
- 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
- S-17136 Solna, Sweden, 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 North America, Inc.
view allRecalls naming K950328
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K950328.
Data sourced from openFDA. This site is unofficial and independent of the FDA.