PACIFIC HEMOSTASIS THROMBOPLASTIN D

Test, Time, Prothrombin

PACIFIC HEMOSTASIS

The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Pacific Hemostasis Thromboplastin D.

Pre-market Notification Details

Device IDK994100
510k NumberK994100
Device Name:PACIFIC HEMOSTASIS THROMBOPLASTIN D
ClassificationTest, Time, Prothrombin
Applicant PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville,  NC  28078 -8144
ContactLaura A Worfolk
CorrespondentLaura A Worfolk
PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville,  NC  28078 -8144
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-03
Decision Date2000-02-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275000795 K994100 000
00845275000542 K994100 000

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