Cleared Traditional

ENZIP URINARY MICROALBUMIN TEST

K922032 · Diagnostic Specialties · Chemistry
Jul 1992
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K922032 is an FDA 510(k) clearance for the ENZIP URINARY MICROALBUMIN TEST, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Diagnostic Specialties (Metuchen, US). The FDA issued a Cleared decision on July 30, 1992, 90 days after receiving the submission on May 1, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K922032 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1992
Decision Date July 30, 1992
Days to Decision 90 days
Submission Type Traditional
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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