REFEREE BRAND CO-OXIMETER REAGENTS

Whole Blood Hemoglobin Determination

ANALYTICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Referee Brand Co-oximeter Reagents.

Pre-market Notification Details

Device IDK830180
510k NumberK830180
Device Name:REFEREE BRAND CO-OXIMETER REAGENTS
ClassificationWhole Blood Hemoglobin Determination
Applicant ANALYTICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKHG  
CFR Regulation Number864.7500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-18
Decision Date1983-04-08

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