The following data is part of a premarket notification filed by Genesis Diagnostics Ltd. with the FDA for Gliadin Antibodies Elisa.
| Device ID | K973910 |
| 510k Number | K973910 |
| Device Name: | GLIADIN ANTIBODIES ELISA |
| Classification | Antibodies, Gliadin |
| Applicant | GENESIS DIAGNOSTICS LTD. EDEN RESEARCH PARK HENRY CRABB RD. Littleport, Cambridgeshire, GB Cb6 1se |
| Contact | Michael Walker |
| Correspondent | Michael Walker GENESIS DIAGNOSTICS LTD. EDEN RESEARCH PARK HENRY CRABB RD. Littleport, Cambridgeshire, GB Cb6 1se |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1999-02-17 |