SERALYZER HEMOGLOBIN REAGENT STRIPS

Whole Blood Hemoglobin Determination

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Seralyzer Hemoglobin Reagent Strips.

Pre-market Notification Details

Device IDK822044
510k NumberK822044
Device Name:SERALYZER HEMOGLOBIN REAGENT STRIPS
ClassificationWhole Blood Hemoglobin Determination
Applicant MILES LABORATORIES, 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 Received1982-07-12
Decision Date1982-07-30

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