THROMBOSCREEN THROMBOPLASTIN-DS

Test, Time, Prothrombin

PACIFIC HEMOSTASIS

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

Pre-market Notification Details

Device IDK940082
510k NumberK940082
Device Name:THROMBOSCREEN THROMBOPLASTIN-DS
ClassificationTest, Time, Prothrombin
Applicant PACIFIC HEMOSTASIS 11515 VANSTORY DR. STE. 125 Huntersville,  NC  28078
ContactJames Maynard, Ph.d
CorrespondentJames Maynard, Ph.d
PACIFIC HEMOSTASIS 11515 VANSTORY DR. STE. 125 Huntersville,  NC  28078
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-07
Decision Date1995-02-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275000801 K940082 000
00845275000535 K940082 000
00845275000528 K940082 000

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