HEMOGLOBIN REAGENT

Whole Blood Hemoglobin Determination

ANCO MEDICAL REAGENTS & ASSOC.

The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Hemoglobin Reagent.

Pre-market Notification Details

Device IDK821658
510k NumberK821658
Device Name:HEMOGLOBIN REAGENT
ClassificationWhole Blood Hemoglobin Determination
Applicant ANCO MEDICAL REAGENTS & ASSOC. 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 Received1982-06-04
Decision Date1982-06-25

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