ABC FP ANALYZER

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

INTL. BIOCLINICAL, INC.

The following data is part of a premarket notification filed by Intl. Bioclinical, Inc. with the FDA for Abc Fp Analyzer.

Pre-market Notification Details

Device IDK883533
510k NumberK883533
Device Name:ABC FP ANALYZER
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland,  OR  97202
ContactJanelle M Batley
CorrespondentJanelle M Batley
INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland,  OR  97202
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-18
Decision Date1988-12-15

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