HISTOPLASMA CAPSULATUM, ANTISERUM
FDA 510(k) clearance K792711 · decided 1980-01-17
Clearance details
- K-number
- K792711
- 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
- GMJ
- 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 |
|---|---|---|
| LA-HISTO ANTIBODY SYSTEM #HL 1001 (K830837) | Immuno-Mycologics, Inc. | 1983-05-05 |
| MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL (K813359) | American Scientific Products | 1981-12-31 |
| IMMUNO. IDENTIFICATION OF H. CAPSULATUM (K802130) | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| HISTOPLASMA CAPSULATUM, ANTIGEN (K792701) | Meridian Diagnostics, Inc. | 1980-01-23 |
| HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (K792708) | Meridian Diagnostics, Inc. | 1980-01-17 |
| HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (K792704) | Meridian Diagnostics, Inc. | 1980-01-17 |
| HISTOPLASMA MYCELIAL #CF10020X (K791394) | Immuno-Mycologics, Inc. | 1979-08-16 |
| FUNGAL IMMUNODIFFUSION KIT #ID1001 (K791384) | Immuno-Mycologics, Inc. | 1979-08-16 |
| HISTOPLASMA YEAST ANTI #CF10021X (K791393) | Immuno-Mycologics, Inc. | 1979-08-16 |
| HISTOPLASMA YEAST ANTIGEN (K760827) | I M, Inc. | 1976-11-01 |
| HISTOPLASMA MYCELIAL ANTIGEN (K760826) | I M, Inc. | 1976-11-01 |
Recalls involving this device
No recalls on record reference this clearance.