The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Thromborel S.
| Device ID | K003870 |
| 510k Number | K003870 |
| Device Name: | THROMBOREL S |
| Classification | Test, Time, Prothrombin |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-15 |
| Decision Date | 2001-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414023465 | K003870 | 000 |
| 00630414023441 | K003870 | 000 |
| 00842768011337 | K003870 | 000 |
| 00842768011306 | K003870 | 000 |
| 00842768018749 | K003870 | 000 |