ASTRA-T CALCIUM REAGENT

Cresolphthalein Complexone, Calcium

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Astra-t Calcium Reagent.

Pre-market Notification Details

Device IDK820090
510k NumberK820090
Device Name:ASTRA-T CALCIUM REAGENT
ClassificationCresolphthalein Complexone, Calcium
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-13
Decision Date1982-01-28

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