The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Bcs System.
| Device ID | K013114 |
| 510k Number | K013114 |
| Device Name: | BCS SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JPA |
| Subsequent Product Code | GGP |
| Subsequent Product Code | GIR |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-18 |
| Decision Date | 2001-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768007491 | K013114 | 000 |
| 00842768019654 | K013114 | 000 |
| 00842768019661 | K013114 | 000 |