MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

Assay, Glycosylated Hemoglobin

DIAZYME LABORATORIES

The following data is part of a premarket notification filed by Diazyme Laboratories with the FDA for Modification To: Direct Enzymatic Hba1c Assay Kit, Model# Dz168a, Dz168a-cal, Dz168a-con.

Pre-market Notification Details

Device IDK070734
510k NumberK070734
Device Name:MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
ClassificationAssay, Glycosylated Hemoglobin
Applicant DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
ContactAbhijit Datta
CorrespondentAbhijit Datta
DIAZYME LABORATORIES 3550 GENERAL ATOMICS CT. San Diego,  CA  92121
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-16
Decision Date2007-04-09

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