Cleared Traditional

AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT

K912733 · Amersham Corp. · Chemistry
Jul 1991
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K912733 is an FDA 510(k) clearance for the AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on July 22, 1991, 32 days after receiving the submission on June 20, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K912733 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1991
Decision Date July 22, 1991
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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