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FDA 510(k)

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071

K-Number: K043460 · 2005-01-31

ApplicantOlympus America, Inc.
Decision Date2005-01-31
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2005-01-31 under 510(k) number K043460. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071?

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 is a medical device that received FDA 510(k) clearance on 2005-01-31. The listed applicant is Olympus America, Inc.. The 510(k) number is K043460.

When did OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 receive FDA 510(k) clearance?

OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 received FDA 510(k) clearance on 2005-01-31, under 510(k) number K043460.

Who is the listed applicant for OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071?

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

What is the FDA product code for OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071?

The FDA product code for OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 is JIX.

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Related Devices (Code: JIX)

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K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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