The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Cmv Igm Elisa Test System.
| Device ID | K896355 |
| 510k Number | K896355 |
| Device Name: | CMV IGM ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Jerry W Pickering |
| Correspondent | Jerry W Pickering ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1990-02-27 |