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FDA 510(k)

CLINILAB AUTOMATED URINALYSIS SYSTEM

K-Number: K761306 · 1977-03-21

ApplicantMiles Laboratories, Inc.
Decision Date1977-03-21
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINILAB AUTOMATED URINALYSIS SYSTEM 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 1977-03-21 under 510(k) number K761306. 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 CLINILAB AUTOMATED URINALYSIS SYSTEM?

CLINILAB AUTOMATED URINALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1977-03-21. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K761306.

When did CLINILAB AUTOMATED URINALYSIS SYSTEM receive FDA 510(k) clearance?

CLINILAB AUTOMATED URINALYSIS SYSTEM received FDA 510(k) clearance on 1977-03-21, under 510(k) number K761306.

Who is the listed applicant for CLINILAB AUTOMATED URINALYSIS SYSTEM?

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 CLINILAB AUTOMATED URINALYSIS SYSTEM?

The FDA product code for CLINILAB AUTOMATED URINALYSIS SYSTEM 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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