ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT

Assay, Bart's, Hemoglobin

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Alpha-thal Screen 20 Test Kit & 100 Kit.

Pre-market Notification Details

Device IDK801771
510k NumberK801771
Device Name:ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
ClassificationAssay, Bart's, Hemoglobin
Applicant ISOLAB, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLGL  
CFR Regulation Number864.7500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-07-28
Decision Date1981-01-16

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