ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
FDA 510(k) clearance K081325 · decided 2008-07-24
Clearance details
- K-number
- K081325
- Device name
- ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
- Applicant
- Ab Biodisk
- Decision
- Substantially Equivalent
- Date received
- 2008-05-12
- Decision date
- 2008-07-24
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- JWY
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Solna, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is recall (Z-1526-2017) | BioMerieux SA | 2017-03-21 |