HISTOPLASMA CAPSULATUM, ANTISERUM
FDA 510(k) clearance K792718 · decided 1980-01-17
Clearance details
- K-number
- K792718
- Device name
- HISTOPLASMA CAPSULATUM, ANTISERUM
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-27
- Decision date
- 1980-01-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- GMK
- Device class
- 2
- Regulation number
- 866.3320
- 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 |
|---|---|---|
| NEGATIVE CONTROL SERUM (K792694) | Meridian Diagnostics, Inc. | 1980-01-24 |
| IMMUNODIFFUSION BAND INTENSIFYING FLUID (K792692) | Meridian Diagnostics, Inc. | 1980-01-24 |
| HISTOPLASMA CAPSULATUM, ANTISERUM (K792679) | Meridian Diagnostics, Inc. | 1980-01-17 |
| ANTI-BLASTOMYCES SERUM #CF10027X (K791390) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-HISTOPLASMA SERUM #CF10025X (K791395) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-HISTOPLASMA SERUM #CF10026X (K791392) | Immuno-Mycologics, Inc. | 1979-08-16 |
| ANTI-HISTOPLASMA CONTROL SERUM (YEAST) (K760832) | I M, Inc. | 1976-11-01 |
| ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) (K760831) | I M, Inc. | 1976-11-01 |
Recalls involving this device
No recalls on record reference this clearance.