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FDA 510(k)

URITEST 10 URINALYSIS REAGENT STRIPS

K-Number: K052719 · 2006-12-05

ApplicantArj Medical, Inc.
Decision Date2006-12-05
Product CodeCDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URITEST 10 URINALYSIS REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Arj Medical, Inc.. It received FDA 510(k) clearance on 2006-12-05 under 510(k) number K052719. The device is classified under product code CDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITEST 10 URINALYSIS REAGENT STRIPS?

URITEST 10 URINALYSIS REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Arj Medical, Inc.. The 510(k) number is K052719.

When did URITEST 10 URINALYSIS REAGENT STRIPS receive FDA 510(k) clearance?

URITEST 10 URINALYSIS REAGENT STRIPS received FDA 510(k) clearance on 2006-12-05, under 510(k) number K052719.

Who is the listed applicant for URITEST 10 URINALYSIS REAGENT STRIPS?

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

What is the FDA product code for URITEST 10 URINALYSIS REAGENT STRIPS?

The FDA product code for URITEST 10 URINALYSIS REAGENT STRIPS is CDM.

Related Clinical Trials

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.

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Other records listing Arj Medical, 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.

K091472URITEST 50 AND URITEST 500 URINE ANALYZERK052708PYLO-PLUS

Related Devices (Code: CDM)

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.

K061559ACON URINALYSIS REAGENT STRIPSAcon Laboratories Co.K880584URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8CMach Diag. C/O Wichita State UniversityK873366WAKO(TM) PRETEST 5AWako Chemicals USA, Inc.K852611TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINEMiles Laboratories, Inc.K821799FITKIT I CHECKUP KITPatton, Boggs & BlowK830340FITKIT I CHECKUP KITBoditestor

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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