CHLAMYDIA GROUP CF ANTIGEN

Antigen, Cf, Psittacosis (chlamydia Group)

HILLCREST BIOLOGICALS

The following data is part of a premarket notification filed by Hillcrest Biologicals with the FDA for Chlamydia Group Cf Antigen.

Pre-market Notification Details

Device IDK844868
510k NumberK844868
Device Name:CHLAMYDIA GROUP CF ANTIGEN
ClassificationAntigen, Cf, Psittacosis (chlamydia Group)
Applicant HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress,  CA  90630
ContactLouis C Cullman
CorrespondentLouis C Cullman
HILLCREST BIOLOGICALS 10703 PROGRESS WAY Cypress,  CA  90630
Product CodeGPW  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-14
Decision Date1985-03-05

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