Cleared Traditional

IRON-PC-SL ASSAY MODEL # 151-10, 151-26

K020816 · Diagnostic Chemicals , Ltd. · Chemistry
May 2002
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K020816 is an FDA 510(k) clearance for the IRON-PC-SL ASSAY MODEL # 151-10, 151-26, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on May 14, 2002, 62 days after receiving the submission on March 13, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K020816 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2002
Decision Date May 14, 2002
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

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