The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Gliadin Iga Elisa Test System.
| Device ID | K990207 |
| 510k Number | K990207 |
| Device Name: | GLIADIN IGA ELISA TEST SYSTEM |
| Classification | Antibodies, Gliadin |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark K Kopnitsky |
| Correspondent | Mark K Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239033703 | K990207 | 000 |
| 04048474033700 | K990207 | 000 |