The following data is part of a premarket notification filed by Scimedx Corp. with the FDA for Gliadin Iga Antibody Eia Detection System.
| Device ID | K002169 |
| 510k Number | K002169 |
| Device Name: | GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM |
| Classification | Antibodies, Gliadin |
| Applicant | SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus SCIMEDX CORP. 400 FORD RD. Denville, NJ 07834 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-18 |
| Decision Date | 2000-10-19 |