Cleared Traditional

MICRO-BUMINTEST REAGENT TABLETS

K874909 · Miles Laboratories, Inc. · Chemistry
Apr 1988
Decision
149d
Days
Class 1
Risk

About This 510(k) Submission

K874909 is an FDA 510(k) clearance for the MICRO-BUMINTEST REAGENT TABLETS, a Indicator Method, Protein Or Albumin (urinary, Non-quant.) (Class I — General Controls, product code JIR), submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on April 28, 1988, 149 days after receiving the submission on December 1, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1645.

Submission Details

510(k) Number K874909 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1987
Decision Date April 28, 1988
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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