Cleared Traditional

BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE

K925132 · Becton Dickinson Advanced Diagnostics · Chemistry
Dec 1992
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K925132 is an FDA 510(k) clearance for the BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Becton Dickinson Advanced Diagnostics (Sparks, US). The FDA issued a Cleared decision on December 28, 1992, 76 days after receiving the submission on October 13, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K925132 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1992
Decision Date December 28, 1992
Days to Decision 76 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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