FAST FLOW #60310

Assay, Glycosylated Hemoglobin

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Fast Flow #60310.

Pre-market Notification Details

Device IDK791365
510k NumberK791365
Device Name:FAST FLOW #60310
ClassificationAssay, Glycosylated Hemoglobin
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-25
Decision Date1979-09-27

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