Cleared Traditional

BIO-SCIENCE LABORATORIES T4 REAGENT

K834023 · Biosan Laboratories, Inc. · Chemistry
Jan 1984
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K834023 is an FDA 510(k) clearance for the BIO-SCIENCE LABORATORIES T4 REAGENT, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Biosan Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1984, 63 days after receiving the submission on November 22, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K834023 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1983
Decision Date January 24, 1984
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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