The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Coagulation System.
| Device ID | K970431 |
| 510k Number | K970431 |
| Device Name: | BEHRING COAGULATION SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers, Jr. |
| Correspondent | Paul L Rogers, Jr. BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-04 |
| Decision Date | 1997-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414945514 | K970431 | 000 |
| 00842768014444 | K970431 | 000 |
| 00842768012198 | K970431 | 000 |
| 00842768008023 | K970431 | 000 |