PACIFIC HEMOSTASIS THROMBOSCREEN 200

Instrument, Coagulation

PACIFIC HEMOSTASIS

The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Pacific Hemostasis Thromboscreen 200.

Pre-market Notification Details

Device IDK991321
510k NumberK991321
Device Name:PACIFIC HEMOSTASIS THROMBOSCREEN 200
ClassificationInstrument, Coagulation
Applicant PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville,  NC  28078 -8144
ContactLarry Kopyta
CorrespondentLarry Kopyta
PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville,  NC  28078 -8144
Product CodeKQG  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-19
Decision Date1999-06-21
Summary:summary

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