The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Test Thrombin.
Device ID | K930157 |
510k Number | K930157 |
Device Name: | TEST THROMBIN |
Classification | Test, Thrombin Time |
Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Contact | Joseph Kiceina |
Correspondent | Joseph Kiceina BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
Product Code | GJA |
CFR Regulation Number | 864.7875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-13 |
Decision Date | 1993-05-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768012716 | K930157 | 000 |
00630414639635 | K930157 | 000 |