17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA

Radioimmunoassay, 17-hydroxyprogesterone

ICN BIOMEDICALS, INC.

The following data is part of a premarket notification filed by Icn Biomedicals, Inc. with the FDA for 17-alpha-hydroxyprogesterone (17-oh-p) Neo. Ria.

Pre-market Notification Details

Device IDK885198
510k NumberK885198
Device Name:17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
ClassificationRadioimmunoassay, 17-hydroxyprogesterone
Applicant ICN BIOMEDICALS, INC. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson,  CA  90746
ContactRobert Hudak
CorrespondentRobert Hudak
ICN BIOMEDICALS, INC. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson,  CA  90746
Product CodeJLX  
CFR Regulation Number862.1395 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-16
Decision Date1989-02-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817830023150 K885198 000

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