ELECSYS FOLATE

Radioassay, Vitamin B12

BOEHRINGER MANNHEIM CORP.

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

Pre-market Notification Details

Device IDK973674
510k NumberK973674
Device Name:ELECSYS FOLATE
ClassificationRadioassay, Vitamin B12
Applicant BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton,  CA  94588 -2722
ContactPatricia Klimley
CorrespondentPatricia Klimley
BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton,  CA  94588 -2722
Product CodeCDD  
CFR Regulation Number862.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-26
Decision Date1997-11-12
Summary:summary

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