SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST

Visual, Pregnancy Hcg, Prescription Use

SYNTRON BIORESEARCH, INC.

The following data is part of a premarket notification filed by Syntron Bioresearch, Inc. with the FDA for Syntron Bioresearch Ez Check Hcg Pregnancy Test.

Pre-market Notification Details

Device IDK870751
510k NumberK870751
Device Name:SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant SYNTRON BIORESEARCH, INC. 4202 SORRENTO VALLEY BLVD. SUITE G San Diego,  CA  92121
ContactShung-ho Chang
CorrespondentShung-ho Chang
SYNTRON BIORESEARCH, INC. 4202 SORRENTO VALLEY BLVD. SUITE G San Diego,  CA  92121
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-25
Decision Date1987-05-20

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