CONTRO II

Multi-analyte Controls, All Kinds (assayed)

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Contro Ii.

Pre-market Notification Details

Device IDK791696
510k NumberK791696
Device Name:CONTRO II
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-31
Decision Date1979-09-24

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