The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ebv-vca Igm Elisa Test Ststem.
Device ID | K944449 |
510k Number | K944449 |
Device Name: | EBV-VCA IGM ELISA TEST STSTEM |
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 | 1994-09-12 |
Decision Date | 1995-09-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840239027948 | K944449 | 000 |
04048474027945 | K944449 | 000 |