PERMIER HISTOPLASMA
FDA 510(k) clearance K915700 · decided 1992-07-30
Clearance details
- K-number
- K915700
- Device name
- PERMIER HISTOPLASMA
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-23
- Decision date
- 1992-07-30
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- MIZ
- Device class
- 2
- Regulation number
- 866.3320
- 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 HISTOPLASMA ANTIGEN EIA MODEL HAG102 (K101407) | Immuno-Mycologics, Inc. | 2011-07-19 |
Recalls involving this device
No recalls on record reference this clearance.