Cleared Traditional

IRI SPEC URINALYSIS CONTROL

K832713 · Intl. Remote Imaging Systems · Chemistry
Dec 1983
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K832713 is an FDA 510(k) clearance for the IRI SPEC URINALYSIS CONTROL, a Urinalysis Controls (assayed And Unassayed) (Class I — General Controls, product code JJW), submitted by Intl. Remote Imaging Systems (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983, 132 days after receiving the submission on August 12, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K832713 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1983
Decision Date December 22, 1983
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJW — Urinalysis Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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