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FDA 510(k)

URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER

K-Number: K980047 · 1998-06-10

ApplicantYeongdong Pharmaceutical Corp.
Decision Date1998-06-10
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Yeongdong Pharmaceutical Corp.. It received FDA 510(k) clearance on 1998-06-10 under 510(k) number K980047. 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 URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER?

URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER is a medical device that received FDA 510(k) clearance on 1998-06-10. The listed applicant is Yeongdong Pharmaceutical Corp.. The 510(k) number is K980047.

When did URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER receive FDA 510(k) clearance?

URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER received FDA 510(k) clearance on 1998-06-10, under 510(k) number K980047.

Who is the listed applicant for URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER?

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

What is the FDA product code for URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER?

The FDA product code for URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER is KQO.

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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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