Cleared Traditional

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

K030860 · Monobind · Chemistry
Aug 2003
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K030860 is an FDA 510(k) clearance for the ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on August 22, 2003, 157 days after receiving the submission on March 18, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K030860 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2003
Decision Date August 22, 2003
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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