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 |