The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Hcg Controls.
Device ID | K954144 |
510k Number | K954144 |
Device Name: | OPUS HCG CONTROLS |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
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 | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-05 |
Decision Date | 1995-10-06 |