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FDA 510(k)

CLINITEK 10 SEMI-AUTO URINALYSIS SYS

K-Number: K842238 · 1984-07-25

ApplicantMiles Laboratories, Inc.
Decision Date1984-07-25
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINITEK 10 SEMI-AUTO URINALYSIS SYS 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 1984-07-25 under 510(k) number K842238. 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 CLINITEK 10 SEMI-AUTO URINALYSIS SYS?

CLINITEK 10 SEMI-AUTO URINALYSIS SYS is a medical device that received FDA 510(k) clearance on 1984-07-25. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K842238.

When did CLINITEK 10 SEMI-AUTO URINALYSIS SYS receive FDA 510(k) clearance?

CLINITEK 10 SEMI-AUTO URINALYSIS SYS received FDA 510(k) clearance on 1984-07-25, under 510(k) number K842238.

Who is the listed applicant for CLINITEK 10 SEMI-AUTO URINALYSIS SYS?

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 CLINITEK 10 SEMI-AUTO URINALYSIS SYS?

The FDA product code for CLINITEK 10 SEMI-AUTO URINALYSIS SYS is KQO.

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Other records listing Miles Laboratories, 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.

K880605LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTERK874909MICRO-BUMINTEST REAGENT TABLETSK875079MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULEK871835GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINTK872120SERALYZER III BLOOD CHEMISTRY ANALYZERK873304CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)

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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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