ELECSYS CALCHECK FSH

Calibrator, Multi-analyte Mixture

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Calcheck Fsh.

Pre-market Notification Details

Device IDK964829
510k NumberK964829
Device Name:ELECSYS CALCHECK FSH
ClassificationCalibrator, Multi-analyte Mixture
Applicant BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord,  CA  94524
ContactYvette Lloyd
CorrespondentYvette Lloyd
BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. Concord,  CA  94524
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-02
Decision Date1996-12-16
Summary:summary

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