DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

Single (specified) Analyte Controls (assayed And Unassayed)

GENERAL ATOMICS

The following data is part of a premarket notification filed by General Atomics with the FDA for Diazyme Homocysteine Enzymatic Assay Kit.

Pre-market Notification Details

Device IDK042448
510k NumberK042448
Device Name:DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego,  CA  92121
ContactHuan Tran
CorrespondentHuan Tran
GENERAL ATOMICS 3550 GENERAL ATOMICS COURT San Diego,  CA  92121
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-09
Decision Date2004-10-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.