Cleared Special

IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25

K022538 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry
Aug 2002
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K022538 is an FDA 510(k) clearance for the IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Diagnostic Chemicals, Ltd. (Usa) (Laguna Hills, US). The FDA issued a Cleared decision on August 23, 2002, 22 days after receiving the submission on August 1, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K022538 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2002
Decision Date August 23, 2002
Days to Decision 22 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIR — Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1645

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