Cleared Traditional

OLYMPUS URINE PH

K905146 · Diagnostic Systems · Chemistry
Feb 1991
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K905146 is an FDA 510(k) clearance for the OLYMPUS URINE PH, a Ph Meter (Class I — General Controls, product code JQY), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on February 4, 1991, 81 days after receiving the submission on November 15, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K905146 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1990
Decision Date February 04, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQY — Ph Meter
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050

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