ELECSYS CALCHECK MYOGLOBIN

Multi-analyte Controls, All Kinds (assayed)

BOEHRINGER MANNHEIM CORP.

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

Pre-market Notification Details

Device IDK983166
510k NumberK983166
Device Name:ELECSYS CALCHECK MYOGLOBIN
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
ContactPriscilla A Hamill
CorrespondentPriscilla A Hamill
BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-10
Decision Date1998-09-22
Summary:summary

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