PHYSIO GAS ANALYZER

Extractable Antinuclear Antibody, Antigen And Control

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Physio Gas Analyzer.

Pre-market Notification Details

Device IDK843423
510k NumberK843423
Device Name:PHYSIO GAS ANALYZER
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
ContactMichael N Kelly
CorrespondentMichael N Kelly
RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
Product CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-31
Decision Date1985-02-26

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