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FDA 510(k)

INSTRUMENTED SYSTEM FOR URINALYSIS

K-Number: K760472 · 1976-10-29

ApplicantMiles Laboratories, Inc.
Decision Date1976-10-29
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INSTRUMENTED SYSTEM FOR URINALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1976-10-29 under 510(k) number K760472. 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 INSTRUMENTED SYSTEM FOR URINALYSIS?

INSTRUMENTED SYSTEM FOR URINALYSIS is a medical device that received FDA 510(k) clearance on 1976-10-29. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K760472.

When did INSTRUMENTED SYSTEM FOR URINALYSIS receive FDA 510(k) clearance?

INSTRUMENTED SYSTEM FOR URINALYSIS received FDA 510(k) clearance on 1976-10-29, under 510(k) number K760472.

Who is the listed applicant for INSTRUMENTED SYSTEM FOR URINALYSIS?

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

What is the FDA product code for INSTRUMENTED SYSTEM FOR URINALYSIS?

The FDA product code for INSTRUMENTED SYSTEM FOR URINALYSIS is KQO.

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Other records listing Miles Laboratories, Inc. as applicant

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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

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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