CALIBRATOR II

Calibrator, Multi-analyte Mixture

HI CHEM, INC.

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

Pre-market Notification Details

Device IDK791694
510k NumberK791694
Device Name:CALIBRATOR II
ClassificationCalibrator, Multi-analyte Mixture
Applicant HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-31
Decision Date1979-09-17

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