Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

Radioassay, Vitamin B12

Diazyme Laboratories

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set.

Pre-market Notification Details

Device IDK161721
510k NumberK161721
Device Name:Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
ClassificationRadioassay, Vitamin B12
Applicant Diazyme Laboratories 12889 Gregg Court Poway,  CA  92130
ContactAbhijit Datta
CorrespondentAbhijit Datta
Diazyme Laboratories 12889 Gregg Court Poway,  CA  92130
Product CodeCDD  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-22
Decision Date2016-09-20

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