UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE

Radioimmunoassay, Luteinizing Hormone

UNITED BIOTECH, INC.

The following data is part of a premarket notification filed by United Biotech, Inc. with the FDA for Ubi Magiwel(tm) Lh Quantitative & Qualitative.

Pre-market Notification Details

Device IDK863442
510k NumberK863442
Device Name:UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View,  CA  94043
ContactJoseph Fu
CorrespondentJoseph Fu
UNITED BIOTECH, INC. 1300C SPACEPARK WAY Mountain View,  CA  94043
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-05
Decision Date1987-02-04

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