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 |