The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Bct System.
| Device ID | K011665 |
| 510k Number | K011665 |
| Device Name: | BCT SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-30 |
| Decision Date | 2001-08-09 |
| Summary: | summary |