The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus (automated) Application Of The Hsv 1/2 Igm Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) For.
| Device ID | K992166 |
| 510k Number | K992166 |
| Device Name: | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| 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 | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 1999-09-03 |