The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Enzygnost(r) Anti-cmv/igm.
| Device ID | K913693 |
| 510k Number | K913693 |
| Device Name: | ENZYGNOST(R) ANTI-CMV/IGM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1992-02-27 |