K981209 is an FDA 510(k) clearance for the MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS. This device is classified as a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II - Special Controls, product code MVM).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on October 22, 1998, 203 days after receiving the submission on April 2, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K981209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 1998 |
| Decision Date | October 22, 1998 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MVM — Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |