CALIBRATOR B 88133

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 B 88133.

Pre-market Notification Details

Device IDK850405
510k NumberK850405
Device Name:CALIBRATOR B 88133
ClassificationCalibrator, Multi-analyte Mixture
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 CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-04
Decision Date1985-04-01

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