The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Bc Thrombin Reagent.
Device ID | K970645 |
510k Number | K970645 |
Device Name: | BC THROMBIN REAGENT |
Classification | Test, Thrombin Time |
Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
Contact | Paul L Rogers, Jr. |
Correspondent | Paul L Rogers, Jr. BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
Product Code | GJA |
CFR Regulation Number | 864.7875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-20 |
Decision Date | 1997-05-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768013102 | K970645 | 000 |