The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Procainamide.
Device ID | K951434 |
510k Number | K951434 |
Device Name: | OPUS PROCAINAMIDE |
Classification | Enzyme Immunoassay, Procainamide |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Nancy M Johansen |
Correspondent | Nancy M Johansen BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | LAR |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-28 |
Decision Date | 1995-07-03 |