The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Cmv-igm Ifa Test System.
Device ID | K900743 |
510k Number | K900743 |
Device Name: | CMV-IGM IFA TEST SYSTEM |
Classification | Antibody Igm,if, Cytomegalovirus Virus |
Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
Contact | W Pickering |
Correspondent | W Pickering ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
Product Code | LKQ |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-16 |
Decision Date | 1990-04-26 |