Txocell-Iha Reagent System
FDA 510(k) K790460 · Calbiochem-Behring Corp.
510(k) numberK790460
Submission
- Device name
- Txocell-Iha Reagent System
- Applicant
- Calbiochem-Behring Corp.
Mchenry, IL, US - Received
- March 5, 1979
- Decision date
- May 25, 1979
- 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 |
| K802452 | Toxotest-Mt Eiken KitGMM · Traditional | Syn-Kit, Inc. | 12/18/1980SE |
| K771560 | Toxha TestGMM · Traditional | Burroughs Wellcome Co. | 09/15/1977SE |
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| K820088 | Aft System Proficiency Testing ProgramDBL · Traditional | 01/26/1982SE |
| K812458 | PadacJTO · Traditional | 09/23/1981SE |
| K810718 | C-Peptice ReagentsJKD · Traditional | 03/31/1981SE |
| K810669 | Pantrak E.K.CIW · Traditional | 03/31/1981SE |
| K810404 | Rheumatoid Factors Reference SerumDHR · Traditional | 03/11/1981SE |
Questions and answers
When was Txocell-Iha Reagent System cleared by the FDA?
Txocell-Iha Reagent System (K790460) received a 510(k) decision of Substantially Equivalent on May 25, 1979, 81 days after the submission was received.
What is the product code of K790460?
The FDA product code is GMM – Antigens, Iha, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.