HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT
FDA 510(k) clearance K851977 · decided 1985-10-16
Clearance details
- K-number
- K851977
- Device name
- HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT
- Applicant
- Si Sero-Immuno Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-07
- Decision date
- 1985-10-16
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- GMM
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tucker, GA, 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 |
|---|---|---|
| TOXOGEN (K981263) | Instrumentation Laboratory CO | 1998-08-06 |
| ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (K952818) | Pyramid Biological Corp. | 1995-11-20 |
| HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT (K851976) | Si Sero-Immuno Diagnostics, Inc. | 1985-10-16 |
| POLYCHACO INDIRECT HEMAGGLUTINATION (K830870) | Parasitic Disease Consultants | 1983-08-12 |
| TOXOTEST-MT EIKEN KIT (K802452) | Syn-Kit, Inc. | 1980-12-18 |
| TXOCELL-IHA REAGENT SYSTEM (K790460) | Calbiochem-Behring Corp. | 1979-05-25 |
| TOXHA TEST (K771560) | Burroughs Wellcome Co. | 1977-09-15 |
Recalls involving this device
No recalls on record reference this clearance.