The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Von Willebrand Reagent.
| Device ID | K972116 |
| 510k Number | K972116 |
| Device Name: | VON WILLEBRAND REAGENT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose, CA 95161 -9013 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-05 |
| Decision Date | 1997-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768038211 | K972116 | 000 |
| 00842768018800 | K972116 | 000 |