510(k) K830870
- Device
- POLYCHACO INDIRECT HEMAGGLUTINATION
- Applicant
- PARASITIC DISEASE CONSULTANTS
- 510(k) number
- K830870
- Product code
- GMM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-12
- Date received
- 1983-03-18
- Regulation
- 866.3780
- Classification name
- Antigens, Iha, Toxoplasma Gondii
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981263 | TOXOGEN | Instrumentation Laboratory CO | 1998-08-06 |
| K952818 | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | Pyramid Biological Corp. | 1995-11-20 |
| K851976 | HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT | Si Sero-Immuno Diagnostics, Inc. | 1985-10-16 |
| K851977 | HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT | Si Sero-Immuno Diagnostics, Inc. | 1985-10-16 |
| K802452 | TOXOTEST-MT EIKEN KIT | Syn-Kit, Inc. | 1980-12-18 |
| K790460 | TXOCELL-IHA REAGENT SYSTEM | Calbiochem-Behring Corp. | 1979-05-25 |
| K771560 | TOXHA TEST | Burroughs Wellcome Co. | 1977-09-15 |
Legacy Summary#
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FDA Review#
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