FACTOR X DEFICIENT PLASMA

Plasma, Coagulation Factor Deficient

MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Factor X Deficient Plasma.

Pre-market Notification Details

Device IDK893523
510k NumberK893523
Device Name:FACTOR X DEFICIENT PLASMA
ClassificationPlasma, Coagulation Factor Deficient
Applicant MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura,  CA  93003
ContactBick, Phd
CorrespondentBick, Phd
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura,  CA  93003
Product CodeGJT  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-08
Decision Date1989-06-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15391521420425 K893523 000

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