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FDA 510(k)

STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS

K-Number: K012829 · 2001-11-02

ApplicantBiocare Corp.
Decision Date2001-11-02
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Biocare Corp.. It received FDA 510(k) clearance on 2001-11-02 under 510(k) number K012829. 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 STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS?

STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Biocare Corp.. The 510(k) number is K012829.

When did STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS receive FDA 510(k) clearance?

STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS received FDA 510(k) clearance on 2001-11-02, under 510(k) number K012829.

Who is the listed applicant for STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS?

The FDA 510(k) record lists Biocare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS?

The FDA product code for STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS is KQO.

Related Clinical Trials

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Other records listing Biocare Corp. 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.

K091414VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DHK002855BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER

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

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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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