The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dade Behring Bftii.
| Device ID | K984501 |
| 510k Number | K984501 |
| Device Name: | DADE BEHRING BFTII |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Contact | Carolyn K George |
| Correspondent | Carolyn K George DADE BEHRING, INC. P.O. BOX 6101 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-18 |
| Decision Date | 1999-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768024887 | K984501 | 000 |
| 00842768012358 | K984501 | 000 |
| 00842768012259 | K984501 | 000 |