GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)

Block, Bite

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Ggt Reagent Cartridge (product No. 88204).

Pre-market Notification Details

Device IDK861893
510k NumberK861893
Device Name:GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
ClassificationBlock, Bite
Applicant HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
ContactAndrew Estrada
CorrespondentAndrew Estrada
HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
Product CodeJXL  
CFR Regulation Number882.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-16
Decision Date1986-06-05

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