PF4 IGG

Platelet Factor 4 Radioimmunoassay

GENETIC TESTING INSTITUTE

The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Pf4 Igg.

Pre-market Notification Details

Device IDK071781
510k NumberK071781
Device Name:PF4 IGG
ClassificationPlatelet Factor 4 Radioimmunoassay
Applicant GENETIC TESTING INSTITUTE 20925 CROSSROADS CIRCLE SUITE 200 Waukesha,  WI  53186 -4054
ContactSuzette C Chance
CorrespondentSuzette C Chance
GENETIC TESTING INSTITUTE 20925 CROSSROADS CIRCLE SUITE 200 Waukesha,  WI  53186 -4054
Product CodeLCO  
CFR Regulation Number864.7695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-02
Decision Date2007-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888234500384 K071781 000
10888234500056 K071781 000
10888234500049 K071781 000

Trademark Results [PF4 IGG]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PF4 IGG
PF4 IGG
77129308 not registered Dead/Abandoned
Genetic Testing Institute, Inc.
2007-03-13

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