PREMIER-CRYPTOCOCCAL ANTIGEN
FDA 510(k) clearance K904393 · decided 1991-01-25
Clearance details
- K-number
- K904393
- Device name
- PREMIER-CRYPTOCOCCAL ANTIGEN
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-25
- Decision date
- 1991-01-25
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- MDU
- Device class
- 2
- Regulation number
- 866.3165
- 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 |
|---|---|---|
| ALPHA CRYPTOCOCCAL ANTIGEN EIA (K120946) | Immuno-Mycologics, Inc. | 2012-12-17 |
Recalls involving this device
No recalls on record reference this clearance.