Cleared Traditional

CEDIA T UPTAKE ASSAY

K954807 · Boehringer Mannheim Corp. · Chemistry
Dec 1995
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K954807 is an FDA 510(k) clearance for the CEDIA T UPTAKE ASSAY, a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ), submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on December 21, 1995, 63 days after receiving the submission on October 19, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number K954807 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1995
Decision Date December 21, 1995
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KHQ — Radioassay, Triiodothyronine Uptake
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1715

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