MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
FDA 510(k) clearance K850291 · decided 1985-05-10
Clearance details
- K-number
- K850291
- Device name
- MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-24
- Decision date
- 1985-05-10
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- JTZ
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm nam recall (Z-0644-2010) | Remel, Inc | 2010-01-15 |