The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus, Automated Application Of The Gliadin Iga Elisa Test System. An Enzyme Linked Immunosorbent Assay, Elisa For.
| Device ID | K001393 |
| 510k Number | K001393 |
| Device Name: | THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR |
| Classification | Antibodies, Gliadin |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-03 |
| Decision Date | 2000-06-07 |