ALPHA CRYPTOCOCCAL ANTIGEN EIA
FDA 510(k) clearance K120946 · decided 2012-12-17
Clearance details
- K-number
- K120946
- Device name
- ALPHA CRYPTOCOCCAL ANTIGEN EIA
- Applicant
- Immuno-Mycologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-29
- Decision date
- 2012-12-17
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- MDU
- Device class
- 2
- Regulation number
- 866.3165
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Norman, OK, 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 |
|---|---|---|
| PREMIER-CRYPTOCOCCAL ANTIGEN (K904393) | Meridian Diagnostics, Inc. | 1991-01-25 |
Recalls involving this device
No recalls on record reference this clearance.