ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

MONOBIND

The following data is part of a premarket notification filed by Monobind with the FDA for Accubind Neonatal T4 Microplate Eia, Model 2625-300.

Pre-market Notification Details

Device IDK030860
510k NumberK030860
Device Name:ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa,  CA  92627
ContactJay Singh
CorrespondentJay Singh
MONOBIND 729 WEST 16TH ST., C-4 Costa Mesa,  CA  92627
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-18
Decision Date2003-08-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840239041098 K030860 000
00816870021256 K030860 000
00816870021249 K030860 000
00816870021232 K030860 000
00816870021225 K030860 000
00816870021218 K030860 000
04048474041095 K030860 000

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