The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Proc Apc Assay, Proc Control Plasma.
| Device ID | K962968 |
| 510k Number | K962968 |
| Device Name: | PROC APC ASSAY, PROC CONTROL PLASMA |
| 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 Jr. |
| Correspondent | Paul L Rogers Jr. 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 | 1996-07-30 |
| Decision Date | 1996-12-13 |
| Summary: | summary |