PREMIER BLASTOMYCES
FDA 510(k) clearance K923859 · decided 1992-10-05
Clearance details
- K-number
- K923859
- Device name
- PREMIER BLASTOMYCES
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-31
- Decision date
- 1992-10-05
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- MJL
- Device class
- 2
- Regulation number
- 866.3060
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EPIDURAL CATHETER TRAY (K840201) | Aries Medical, Inc. | 1984-03-02 |
Recalls involving this device
No recalls on record reference this clearance.