COCCIDIOIDES IMMUNODIFFUSION SYSTEM
FDA 510(k) clearance K812190 · decided 1981-08-31
Clearance details
- K-number
- K812190
- Device name
- COCCIDIOIDES IMMUNODIFFUSION SYSTEM
- Applicant
- American Scientific Products
- Decision
- Substantially Equivalent
- Date received
- 1981-08-03
- Decision date
- 1981-08-31
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GMI
- 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 |
|---|---|---|
| OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (K894617) | Schiff & Co. | 1989-10-31 |
| FUNGAL IMMUNODIFFUSION SYSTEM (K812185) | American Scientific Products | 1981-08-25 |
| IMMUNODIFFUSION REAGENTS/SEROLOGICAL (K802129) | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| CANDIDA ALBICANS, ANTIGEN (K792716) | Meridian Diagnostics, Inc. | 1980-01-24 |
| CANDIDA ALBICANS, ANTISERUM (K792713) | Meridian Diagnostics, Inc. | 1980-01-23 |
| COCCIDIOIDES IMMITIS, ANTIGEN (K792689) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES IMMITIS, ANTIGEN (K792682) | Meridian Diagnostics, Inc. | 1980-01-17 |
| COCCIDIOIDES ANTIGEN #CF10023X (K791389) | Immuno-Mycologics, Inc. | 1979-08-16 |
| CANDIDA IMMUNODIFFUSION KIT #CA1001 (K791383) | Immuno-Mycologics, Inc. | 1979-08-16 |
| CANDIDA IMMUNODIFFUSION KIT (K770527) | I M, Inc. | 1978-03-17 |
Recalls involving this device
No recalls on record reference this clearance.