PROC APC ASSAY, PROC CONTROL PLASMA

Test, Qualitative And Quantitative Factor Deficiency

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Proc Apc Assay, Proc Control Plasma.

Pre-market Notification Details

Device IDK962968
510k NumberK962968
Device Name:PROC APC ASSAY, PROC CONTROL PLASMA
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
ContactPaul L Rogers Jr.
CorrespondentPaul L Rogers Jr.
BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-30
Decision Date1996-12-13
Summary:summary

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