Q FEVER IGG IFA TEST

Antiserum, Fluorescent, Q Fever

HILLCREST BIOLOGICALS

The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Q Fever Igg Ifa Test.

Pre-market Notification Details

Device IDK913906
510k NumberK913906
Device Name:Q FEVER IGG IFA TEST
ClassificationAntiserum, Fluorescent, Q Fever
Applicant HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress,  CA  90630
ContactCarolyn Wagner
CorrespondentCarolyn Wagner
HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress,  CA  90630
Product CodeGPJ  
CFR Regulation Number866.3500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-30
Decision Date1992-10-21

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