Cleared Traditional

ISOLAB'S T4 TEST KIT

K951014 · Isolab, Inc. · Chemistry
Oct 1996
Decision
592d
Days
Class 2
Risk

About This 510(k) Submission

K951014 is an FDA 510(k) clearance for the ISOLAB'S T4 TEST KIT, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on October 18, 1996, 592 days after receiving the submission on March 6, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K951014 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1995
Decision Date October 18, 1996
Days to Decision 592 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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