510(k) K792717
- Device
- COCCIDIOIDES IMMITIS, ANTISERUM POS.
- Applicant
- MERIDIAN DIAGNOSTICS, INC.
- 510(k) number
- K792717
- Product code
- GMH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-17
- Date received
- 1979-12-27
- Regulation
- 866.3135
- Classification name
- Antiserum, Positive Control, Coccidioides Immitis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1524213
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792684 | COCCIDIOIDES IMMITIS, ANTISERUM, | Meridian Diagnostics, Inc. | 1980-01-17 |
| K792688 | COCCIDIOIDES IMMITIS, ANTISERUM | Meridian Diagnostics, Inc. | 1980-01-17 |
| K791388 | ANTI-COCCIDIOIDES SERUM #CF10028X | Immuno-Mycologics, Inc. | 1979-08-16 |
| K760834 | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) | I M, Inc. | 1976-11-01 |
Legacy Summary#
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FDA Review#
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