The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Scientific Inc., Anti-ebv Ea Igg Elisa.
Device ID | K981120 |
510k Number | K981120 |
Device Name: | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA |
Classification | Epstein-barr Virus, Other |
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 | LSE |
CFR Regulation Number | 866.3235 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-27 |
Decision Date | 1998-08-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840239027962 | K981120 | 000 |
04048474027969 | K981120 | 000 |