The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Enzygnost Toxoplasmosis/igm.
Device ID | K913505 |
510k Number | K913505 |
Device Name: | ENZYGNOST TOXOPLASMOSIS/IGM |
Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
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 | LGD |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-07 |
Decision Date | 1992-03-04 |