Cleared Traditional

BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS

K961566 · Biocircuits Corp. · Chemistry
Nov 1996
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K961566 is an FDA 510(k) clearance for the BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Biocircuits Corp. (Sunnyvale, US). The FDA issued a Cleared decision on November 18, 1996, 209 days after receiving the submission on April 23, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K961566 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1996
Decision Date November 18, 1996
Days to Decision 209 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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