COCCIDIOIDES MYCELIAL ANTIGEN
FDA 510(k) clearance K760829 · decided 1976-11-01
Clearance details
- K-number
- K760829
- Device name
- COCCIDIOIDES MYCELIAL ANTIGEN
- Applicant
- I M, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-13
- Decision date
- 1976-11-01
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- GMG
- Device class
- 2
- Regulation number
- 866.3135
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| COCCIDIOIDES LATEX AGGLUTINATION (K812189) | American Scientific Products | 1981-08-25 |
| COCCIDIOIDES IMMITIS, LATEX AGGLUTI (K792690) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIODES (COCCI) (K791381) | Immuno-Mycologics, Inc. | 1979-08-16 |
| REAGENT, COCCI LATEX (K782070) | I M, Inc. | 1979-02-01 |
Recalls involving this device
No recalls on record reference this clearance.