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FDA 510(k)

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

K-Number: K984014 · 1998-12-23

ApplicantBeckman Coulter, Inc.
Decision Date1998-12-23
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 1998-12-23 under 510(k) number K984014. 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 SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2?

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 is a medical device that received FDA 510(k) clearance on 1998-12-23. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K984014.

When did SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 receive FDA 510(k) clearance?

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 received FDA 510(k) clearance on 1998-12-23, under 510(k) number K984014.

Who is the listed applicant for SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2?

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

What is the FDA product code for SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2?

The FDA product code for SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 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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