The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Fibrintimer A.
| Device ID | K926551 |
| 510k Number | K926551 |
| Device Name: | BEHRING FIBRINTIMER A |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Lori Baranauskas |
| Correspondent | Lori Baranauskas BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-31 |
| Decision Date | 1995-04-18 |