Cleared Traditional

TOTAL THROXINE MICROPLATE EIA(225-300)

K971709 · Monobind · Chemistry
Jun 1997
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K971709 is an FDA 510(k) clearance for the TOTAL THROXINE MICROPLATE EIA(225-300), 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 June 16, 1997, 39 days after receiving the submission on May 8, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K971709 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1997
Decision Date June 16, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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