FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
RAPIDEC CARBA NP
K Number: K162385
·
Decision Apr 27, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
16
Review Days
245
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Basic Information
- Device Name
- RAPIDEC CARBA NP
- K Number
- K162385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomerieux S.A.
- Date Received
- August 25, 2016
- Decision Date
- April 27, 2017
- Product Code
- PTJ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PTJ | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PTJ), ordered by most recent decision date.
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FDA 510(k)
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Other Clearances by Biomerieux S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Apr 30, 2025 | Substantially Equivalent |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | Nov 12, 2021 | Substantially Equivalent |
| K192738 | ETEST Delafloxacin (DFX) (0.002-32 µg/mL) | Nov 26, 2019 | Substantially Equivalent |
| K192050 | ETEST Eravacycline (ERV) (0.002 32 µg/mL) | Sep 27, 2019 | Substantially Equivalent |
| K191953 | ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) | Aug 22, 2019 | Substantially Equivalent |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | May 1, 2019 | Substantially Equivalent |
| K183031 | ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) | Jan 11, 2019 | Substantially Equivalent |
| K181092 | CHROMID CARBA agar (CARB) | Jul 6, 2018 | Substantially Equivalent |
| K180936 | ETEST Telavancin (TLA) (0.002-32 ug/mL) | Jul 3, 2018 | Substantially Equivalent |
| K151873 | Etest Ceftaroline (0.002 - 32ug/ml) | Oct 7, 2015 | Substantially Equivalent |