OLYMPUS URINE PH— 510(k) K905146

Substantially Equivalent

Diagnostic Systems

FDA 510(k) clearance K905146 for OLYMPUS URINE PH, Substantially Equivalent on 1991-02-04. Applicant: Diagnostic Systems. Device class: 1.

Clearance details

Applicant: Diagnostic Systems
Product code: Code JQY
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1990-11-15
Decision date: 1991-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.