SICKLE-STAT HEMOGLOBIN S SCREEN KIT

Test, Sickle Cell

CLINICAL TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Sickle-stat Hemoglobin S Screen Kit.

Pre-market Notification Details

Device IDK841272
510k NumberK841272
Device Name:SICKLE-STAT HEMOGLOBIN S SCREEN KIT
ClassificationTest, Sickle Cell
Applicant CLINICAL TECHNOLOGY CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGHM  
CFR Regulation Number864.7825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-27
Decision Date1984-04-13

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