ELECSYS CALCHECK ESTRADIOL

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 Estradiol.

Pre-market Notification Details

Device IDK970148
510k NumberK970148
Device Name:ELECSYS CALCHECK ESTRADIOL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord,  CA  94524 -4117
ContactYvette Lloyd
CorrespondentYvette Lloyd
BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord,  CA  94524 -4117
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-15
Decision Date1997-02-10

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