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FDA 510(k)

OLYMPUS URINE PH

K-Number: K905146 · 1991-02-04

ApplicantDiagnostic Systems
Decision Date1991-02-04
Product CodeJQY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS URINE PH is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1991-02-04 under 510(k) number K905146. The device is classified under product code JQY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS URINE PH?

OLYMPUS URINE PH is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Diagnostic Systems. The 510(k) number is K905146.

When did OLYMPUS URINE PH receive FDA 510(k) clearance?

OLYMPUS URINE PH received FDA 510(k) clearance on 1991-02-04, under 510(k) number K905146.

Who is the listed applicant for OLYMPUS URINE PH?

The FDA 510(k) record lists Diagnostic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS URINE PH?

The FDA product code for OLYMPUS URINE PH is JQY.

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Other records listing Diagnostic Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K893691EMDS CREATINE KINASE ITEM NIMBER 65411K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405K893966HDL PRECIPITATING REAGENTK884993VISUAL BLOOD GLUCOSE TEST SYSTEMK881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641K880787EASY-TEST LACTIC ACID (LA)

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Related Devices (Code: JQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K952178PH-DETECT TESTDiagnostic Reagents, Inc.K872888CIBA CORNING 288 PH/BLOOD GAS SYSTEMCiba Corning Diagnostics Corp.K770347METER, PH, DIGITAL, MODEL 3560Beckman Instruments, Inc.K770352METER, IV PH, MODEL EXPANDOMATICBeckman Instruments, Inc.K770351METER, IV PH, MODEL ZEROMATICBeckman Instruments, Inc.K760789PH METER-130 (.001 PH)Corning Medical & Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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