ELECSYS CALCHECK CK-MB

Single (specified) Analyte Controls (assayed And Unassayed)

BOEHRINGER MANNHEIM CORP.

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

Pre-market Notification Details

Device IDK963182
510k NumberK963182
Device Name:ELECSYS CALCHECK CK-MB
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis,  IN  46250 -0457
ContactJohn D Stevens
CorrespondentJohn D Stevens
BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis,  IN  46250 -0457
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-14
Decision Date1996-08-23
Summary:summary

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