Cleared Traditional

THERACHEM-PLUS, TRI-LEVEL TDC (TM)

K861185 · Fisher Scientific Co., LLC · Toxicology
May 1986
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K861185 is an FDA 510(k) clearance for the THERACHEM-PLUS, TRI-LEVEL TDC (TM), a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Fisher Scientific Co., LLC (Orangeburg, US). The FDA issued a Cleared decision on May 23, 1986, 53 days after receiving the submission on March 31, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K861185 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1986
Decision Date May 23, 1986
Days to Decision 53 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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