The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Protein C Reagent, Coagulometric.
Device ID | K924425 |
510k Number | K924425 |
Device Name: | PROTEIN C REAGENT, COAGULOMETRIC |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Lori Baranauskas |
Correspondent | Lori Baranauskas BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-01 |
Decision Date | 1995-01-24 |