K790460 is an FDA 510(k) clearance for the TXOCELL-IHA REAGENT SYSTEM. This device is classified as a Antigens, Iha, Toxoplasma Gondii (Class II - Special Controls, product code GMM).
Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1979, 81 days after receiving the submission on March 5, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K790460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1979 |
| Decision Date | May 25, 1979 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMM — Antigens, Iha, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |