FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN

Instrument, Coagulation, Automated

FISHER DIAGNOSTICS

The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin.

Pre-market Notification Details

Device IDK023362
510k NumberK023362
Device Name:FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
ClassificationInstrument, Coagulation, Automated
Applicant FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown,  VA  22645 -0307
ContactJerald Steiner
CorrespondentJerald Steiner
FISHER DIAGNOSTICS 8365 VALLEY PIKE Middletown,  VA  22645 -0307
Product CodeGKP  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-07
Decision Date2002-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275000825 K023362 000

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