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FDA 510(k)

HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

K-Number: K053253 · 2006-02-17

ApplicantHemocue AB
Decision Date2006-02-17
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOCUE ALBUMIN 201 ANALYZING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue AB. It received FDA 510(k) clearance on 2006-02-17 under 510(k) number K053253. 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 HEMOCUE ALBUMIN 201 ANALYZING SYSTEM?

HEMOCUE ALBUMIN 201 ANALYZING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Hemocue AB. The 510(k) number is K053253.

When did HEMOCUE ALBUMIN 201 ANALYZING SYSTEM receive FDA 510(k) clearance?

HEMOCUE ALBUMIN 201 ANALYZING SYSTEM received FDA 510(k) clearance on 2006-02-17, under 510(k) number K053253.

Who is the listed applicant for HEMOCUE ALBUMIN 201 ANALYZING SYSTEM?

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

What is the FDA product code for HEMOCUE ALBUMIN 201 ANALYZING SYSTEM?

The FDA product code for HEMOCUE ALBUMIN 201 ANALYZING SYSTEM is KQO.

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 Hemocue AB 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.

K201217HemoCue Hb 301 SystemK181751HemoCue Hb 801 SystemK071652HEMOCUE WBC SYSTEMK060765HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712K061047HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801

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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