ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)
FDA 510(k) clearance K760834 · decided 1976-11-01
Clearance details
- K-number
- K760834
- Device name
- ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)
- 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
- GMH
- 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 IMMITIS, ANTISERUM POS. (K792717) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES IMMITIS, ANTISERUM (K792688) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES IMMITIS, ANTISERUM, (K792684) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ANTI-COCCIDIOIDES SERUM #CF10028X (K791388) | Immuno-Mycologics, Inc. | 1979-08-16 |
Recalls involving this device
No recalls on record reference this clearance.