NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k) clearance K964491 · decided 1997-02-07
Clearance details
- K-number
- K964491
- Device name
- NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- Applicant
- Unipath , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-07
- Decision date
- 1997-02-07
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in c recall (Z-0793-2014) | Remel Inc | 2014-01-21 |