Cleared Traditional

ELECSYS T4 ASSAY

K961490 · Boehringer Mannheim Corp. · Chemistry
Jun 1996
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K961490 is an FDA 510(k) clearance for the ELECSYS T4 ASSAY, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on June 13, 1996, 56 days after receiving the submission on April 18, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K961490 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1996
Decision Date June 13, 1996
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDX — Radioimmunoassay, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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