HICHEM ENZYME VERIFIER KIT

Enzyme Controls (assayed And Unassayed)

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Hichem Enzyme Verifier Kit.

Pre-market Notification Details

Device IDK943684
510k NumberK943684
Device Name:HICHEM ENZYME VERIFIER KIT
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
ContactWynn Stocking
CorrespondentWynn Stocking
HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-29
Decision Date1994-10-04

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