Toxotest-Mt Eiken Kit
FDA 510(k) K802452 · Syn-Kit, Inc.
510(k) numberK802452
Submission
- Device name
- Toxotest-Mt Eiken Kit
- Applicant
- Syn-Kit, Inc.
Walker, MI, US - Received
- October 8, 1980
- Decision date
- December 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GMM – Antigens, Iha, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code GMM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K981263 | ToxogenGMM · Traditional | Instrumentation Laboratory CO | 08/06/1998SE |
| K952818 | Enzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiGMM · Traditional | Pyramid Biological Corp. | 11/20/1995SE |
| K851977 | Hem Ave-Toxo Titration Hemagglutination Test KitGMM · Traditional | Si Sero-Immuno Diagnostics, Inc. | 10/16/1985SE |
| K851976 | Hem Ave-Toxo Screening Hemagglutination Test KitGMM · Traditional | Si Sero-Immuno Diagnostics, Inc. | 10/16/1985SE |
| K830870 | Polychaco Indirect HemagglutinationGMM · Traditional | Parasitic Disease Consultants | 08/12/1983SE |
| K790460 | Txocell-Iha Reagent SystemGMM · Traditional | Calbiochem-Behring Corp. | 05/25/1979SE |
| K771560 | Toxha TestGMM · Traditional | Burroughs Wellcome Co. | 09/15/1977SE |
More from Burroughs Wellcome Co.
| 510(k) | Device | Decision |
|---|---|---|
| K861098 | Seroiden Strepto Kit 'Eiken'GTZ · Traditional | 08/12/1986SE |
| K861631 | Slide Culture U 'Eiken'JXA · Traditional | 06/10/1986SE |
| K854819 | CPR Slide EikenDCN · Traditional | 02/26/1986SE |
| K854820 | Ra 80 EikenDHR · Traditional | 01/17/1986SE |
| K853276 | Aso Slide EikenGTQ · Traditional | 08/20/1985SE |
| K843760 | Uropaper Eiken GJIL · Traditional | 12/18/1984SE |
| K843759 | Uropaper Eiken HagJIL · Traditional | 12/18/1984SE |
| K843758 | Uropaper Eiken GKJIL · Traditional | 12/18/1984SE |
| K843757 | Uropaper Eiken AGJIL · Traditional | 12/18/1984SE |
| K843756 | Uropaper Eiken 5JIL · Traditional | 12/18/1984SE |
Questions and answers
When was Toxotest-Mt Eiken Kit cleared by the FDA?
Toxotest-Mt Eiken Kit (K802452) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 71 days after the submission was received.
What is the product code of K802452?
The FDA product code is GMM – Antigens, Iha, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.