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FDA 510(k)

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT

K-Number: K101852 · 2011-03-23

ApplicantIris International Inc., A Division of Iris Iris I
Decision Date2011-03-23
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT is the device name listed in this FDA 510(k) record. The listed applicant is Iris International Inc., A Division of Iris Iris I. It received FDA 510(k) clearance on 2011-03-23 under 510(k) number K101852. 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 CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT is a medical device that received FDA 510(k) clearance on 2011-03-23. The listed applicant is Iris International Inc., A Division of Iris Iris I. The 510(k) number is K101852.

When did CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT receive FDA 510(k) clearance?

CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT received FDA 510(k) clearance on 2011-03-23, under 510(k) number K101852.

Who is the listed applicant for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

The FDA 510(k) record lists Iris International Inc., A Division of Iris Iris I as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT?

The FDA product code for CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT is KQO.

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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.K091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.K070929ACON U120 URINE ANALYZER, MODEL U111-101ACON Laboratories, 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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