The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Ck-mb & Total Ck Controls.
Device ID | K960275 |
510k Number | K960275 |
Device Name: | OPUS CK-MB & TOTAL CK CONTROLS |
Classification | Enzyme Controls (assayed And Unassayed) |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Nancy M Joansen |
Correspondent | Nancy M Joansen BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | JJT |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-19 |
Decision Date | 1996-04-25 |
Summary: | summary |