Cleared Traditional

TSH CONTROL

K915325 · Polymedco, Inc. · Chemistry
Mar 1992
Decision
101d
Days
Class 1
Risk

About This 510(k) Submission

K915325 is an FDA 510(k) clearance for the TSH CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on March 2, 1992, 101 days after receiving the submission on November 22, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K915325 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1991
Decision Date March 02, 1992
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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