Cleared Traditional

ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

K982250 · Beckman Instruments, Inc. · Chemistry
Jul 1998
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K982250 is an FDA 510(k) clearance for the ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on July 14, 1998, 18 days after receiving the submission on June 26, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K982250 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1998
Decision Date July 14, 1998
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEC — Radioimmunoassay, Free Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1695

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