ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003

Immunoassay, Anti-seizure Drug

ARK DIAGNOSTICS,INC

The following data is part of a premarket notification filed by Ark Diagnostics,inc with the FDA for Ark Zonisamide Assay, Ark Zonisamide Calibrator, And Ark Zonisamide Contro, Models 5022-0001-00, 5022-0002-00, 5022-0003.

Pre-market Notification Details

Device IDK091884
510k NumberK091884
Device Name:ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
ClassificationImmunoassay, Anti-seizure Drug
Applicant ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE Sunnyvale,  CA  94089
ContactJohnny Valdez
CorrespondentJohnny Valdez
ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE Sunnyvale,  CA  94089
Product CodeNWM  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-24
Decision Date2009-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858724003131 K091884 000
00858724003070 K091884 000
00858724003018 K091884 000

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