Toxogen
FDA 510(k) K981263 · Instrumentation Laboratory CO
510(k) numberK981263
Submission
- Device name
- Toxogen
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- April 7, 1998
- Decision date
- August 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K802452 | Toxotest-Mt Eiken KitGMM · Traditional | Syn-Kit, Inc. | 12/18/1980SE |
| K790460 | Txocell-Iha Reagent SystemGMM · Traditional | Calbiochem-Behring Corp. | 05/25/1979SE |
| K771560 | Toxha TestGMM · Traditional | Burroughs Wellcome Co. | 09/15/1977SE |
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Questions and answers
When was Toxogen cleared by the FDA?
Toxogen (K981263) received a 510(k) decision of Substantially Equivalent on August 6, 1998, 121 days after the submission was received.
What is the product code of K981263?
The FDA product code is GMM – Antigens, Iha, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.