The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus (automated) Application Of The Vzv Igg Elisa Test System.
Device ID | K984181 |
510k Number | K984181 |
Device Name: | THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM |
Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
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 | LFY |
CFR Regulation Number | 866.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-23 |
Decision Date | 1999-01-22 |