Cleared Traditional

OPUS(R) PLUS ANALYZER

K913295 · Pb Diagnostic Systems, Inc. · Chemistry
Sep 1991
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K913295 is an FDA 510(k) clearance for the OPUS(R) PLUS ANALYZER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on September 11, 1991, 49 days after receiving the submission on July 24, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K913295 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1991
Decision Date September 11, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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