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FDA 510(k)

SUPER URINE ANALYZER SYSTEM

K-Number: K870526 · 1987-03-06

ApplicantKyoto Daiichi Kagaku Co., Ltd.
Decision Date1987-03-06
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUPER URINE ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kyoto Daiichi Kagaku Co., Ltd.. It received FDA 510(k) clearance on 1987-03-06 under 510(k) number K870526. 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 SUPER URINE ANALYZER SYSTEM?

SUPER URINE ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is Kyoto Daiichi Kagaku Co., Ltd.. The 510(k) number is K870526.

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

SUPER URINE ANALYZER SYSTEM received FDA 510(k) clearance on 1987-03-06, under 510(k) number K870526.

Who is the listed applicant for SUPER URINE ANALYZER SYSTEM?

The FDA 510(k) record lists Kyoto Daiichi Kagaku Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER URINE ANALYZER SYSTEM?

The FDA product code for SUPER URINE ANALYZER SYSTEM is KQO.

Related Clinical Trials

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.

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Other records listing Kyoto Daiichi Kagaku Co., Ltd. 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.

K870708GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEMK813056AUTOMATED URINALYSIS SYSTEM

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

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

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