Cleared Traditional

IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15

K994035 · Diagnostic Chemicals , Ltd. · Chemistry
Feb 2000
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K994035 is an FDA 510(k) clearance for the IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on February 1, 2000, 64 days after receiving the submission on November 29, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K994035 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1999
Decision Date February 01, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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