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FDA 510(k)

CANTROL URINE DIPSTICK CONTROL TWO LEVELS

K-Number: K853603 · 1985-10-08

ApplicantCanyon Diagnostics, Inc.
Decision Date1985-10-08
Product CodeJJW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CANTROL URINE DIPSTICK CONTROL TWO LEVELS is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-10-08 under 510(k) number K853603. The device is classified under product code JJW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANTROL URINE DIPSTICK CONTROL TWO LEVELS?

CANTROL URINE DIPSTICK CONTROL TWO LEVELS is a medical device that received FDA 510(k) clearance on 1985-10-08. The listed applicant is Canyon Diagnostics, Inc.. The 510(k) number is K853603.

When did CANTROL URINE DIPSTICK CONTROL TWO LEVELS receive FDA 510(k) clearance?

CANTROL URINE DIPSTICK CONTROL TWO LEVELS received FDA 510(k) clearance on 1985-10-08, under 510(k) number K853603.

Who is the listed applicant for CANTROL URINE DIPSTICK CONTROL TWO LEVELS?

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

What is the FDA product code for CANTROL URINE DIPSTICK CONTROL TWO LEVELS?

The FDA product code for CANTROL URINE DIPSTICK CONTROL TWO LEVELS is JJW.

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Other records listing Canyon Diagnostics, Inc. as applicant

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Related Devices (Code: JJW)

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.

K170091UA-Cellular CompleteStreckK110846RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2Randox Laboratories LimitedK103387MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROLACON Laboratories, Inc.K081908CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2Cliniqa CorporationK072640IRISPEC,CA/CB/CCIris DiagnosticsK070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435XBio-Rad, Diagnostics Grp.

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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