BIOCLOT PROTEIN S

Test, Qualitative And Quantitative Factor Deficiency

MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Bioclot Protein S.

Pre-market Notification Details

Device IDK955738
510k NumberK955738
Device Name:BIOCLOT PROTEIN S
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura,  CA  93003
ContactMichael D Bick
CorrespondentMichael D Bick
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura,  CA  93003
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-15
Decision Date1996-02-29

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