The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Enzygnost Anti-cmv/igg + Igm.
Device ID | K901485 |
510k Number | K901485 |
Device Name: | ENZYGNOST ANTI-CMV/IGG + 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 | 1990-03-29 |
Decision Date | 1991-05-20 |