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FDA 510(k)

URINE ANALYZER SYSTEM

K-Number: K840996 · 1984-05-01

ApplicantKyoto Diagnostics, Inc.
Decision Date1984-05-01
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kyoto Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-05-01 under 510(k) number K840996. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE ANALYZER SYSTEM?

URINE ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1984-05-01. The listed applicant is Kyoto Diagnostics, Inc.. The 510(k) number is K840996.

When did URINE ANALYZER SYSTEM receive FDA 510(k) clearance?

URINE ANALYZER SYSTEM received FDA 510(k) clearance on 1984-05-01, under 510(k) number K840996.

Who is the listed applicant for URINE ANALYZER SYSTEM?

The FDA 510(k) record lists Kyoto Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URINE ANALYZER SYSTEM?

The FDA product code for URINE ANALYZER SYSTEM is KQO.

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Other records listing Kyoto Diagnostics, Inc. 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.

K861733ADDITIONAL KYOTEST URINE TEST REAGENT STRIPSK843003GLUCOSE AUTO& STAT GA-1120K842750OSMOTIC PRESSURE AUTO & STAT OM-6010K842168ATAGO URINE SPECIFIC GRAVITY & SERUMK841714KYOTEST 2V, URINE TEST REAGENT STRIPK841715KYOTEST UK URINE TEST REAGENT STRIP

View all 11 devices →

Related Devices (Code: KQO)

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.

K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris IK091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.

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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