The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus(automated)application Of The Sm Elisa Test System.an Enzyme Link Immunosorbent Assay(elisa)for The Detectioo.
| Device ID | K983420 |
| 510k Number | K983420 |
| Device Name: | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO |
| Classification | Anti-sm Antibody, Antigen And Control |
| 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 | LKP |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-29 |
| Decision Date | 1998-11-18 |