The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Monkey Oesophagus Ifa Diagnostic Test Kits.
| Device ID | K981209 |
| 510k Number | K981209 |
| Device Name: | MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| Applicant | THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Product Code | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-10-22 |