The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Coagulation Timer.
Device ID | K955278 |
510k Number | K955278 |
Device Name: | BEHRING COAGULATION TIMER |
Classification | Plasma, Coagulation Control |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Kathleen Dray-lyons |
Correspondent | Kathleen Dray-lyons BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | GGN |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-17 |
Decision Date | 1996-05-30 |
Summary: | summary |