The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dade Thrombin Reagent.
| Device ID | K050928 |
| 510k Number | K050928 |
| Device Name: | DADE THROMBIN REAGENT |
| Classification | System, Fibrinogen Determination |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 Newark, DE 19714 -6101 |
| Contact | Katheleen A Dray-lyons |
| Correspondent | Katheleen A Dray-lyons DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG. 500 M.S. 514; POX 6101 Newark, DE 19714 -6101 |
| Product Code | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-14 |
| Decision Date | 2005-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768039416 | K050928 | 000 |
| 00842768003981 | K050928 | 000 |
| 00842768003950 | K050928 | 000 |
| 00842768003943 | K050928 | 000 |
| 00842768019500 | K050928 | 000 |
| 00842768019494 | K050928 | 000 |
| 00842768019517 | K050928 | 000 |
| 00842768019845 | K050928 | 000 |