REAGENTS FOR DETERM. CO2 IN HUMAN SERUM

Phenolphthalein Colorimetry, Carbon-dioxide

DIAGNOSTIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Diagnostic Solutions, Inc. with the FDA for Reagents For Determ. Co2 In Human Serum.

Pre-market Notification Details

Device IDK800681
510k NumberK800681
Device Name:REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
ClassificationPhenolphthalein Colorimetry, Carbon-dioxide
Applicant DIAGNOSTIC SOLUTIONS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKMS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-26
Decision Date1980-05-30

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