PROGESTERONE SYSTEM BY EIA

Radioimmunoassay, Progesterone

INTL. BIOCLINICAL, INC.

The following data is part of a premarket notification filed by Intl. Bioclinical, Inc. with the FDA for Progesterone System By Eia.

Pre-market Notification Details

Device IDK864156
510k NumberK864156
Device Name:PROGESTERONE SYSTEM BY EIA
ClassificationRadioimmunoassay, Progesterone
Applicant INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland,  OR  97202
ContactBuck, Phd
CorrespondentBuck, Phd
INTL. BIOCLINICAL, INC. DBA AMERICAN BIOCLINICAL 4432 S.E. 16TH AVENUE Portland,  OR  97202
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-23
Decision Date1986-11-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.