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 |