SOMAS LIQUID URINE CONTROL

Multi-analyte Controls, All Kinds (assayed)

SOMAS MEDICAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Somas Medical Industries, Inc. with the FDA for Somas Liquid Urine Control.

Pre-market Notification Details

Device IDK862179
510k NumberK862179
Device Name:SOMAS LIQUID URINE CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant SOMAS MEDICAL INDUSTRIES, INC. 2740 S. HARBOR BLVD. SUITE F Santa Ana,  CA  92704 -5824
ContactSom, Ph.d.
CorrespondentSom, Ph.d.
SOMAS MEDICAL INDUSTRIES, INC. 2740 S. HARBOR BLVD. SUITE F Santa Ana,  CA  92704 -5824
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-09
Decision Date1986-07-01

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