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FDA 510(k)

MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)

K-Number: K033501 · 2003-11-20

ApplicantRoche Diagnostics Corp.
Decision Date2003-11-20
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K033501. 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 MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)?

MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K033501.

When did MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) receive FDA 510(k) clearance?

MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) received FDA 510(k) clearance on 2003-11-20, under 510(k) number K033501.

Who is the listed applicant for MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)?

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

What is the FDA product code for MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)?

The FDA product code for MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) is JIX.

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Other records listing Roche Diagnostics Corp. as applicant

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K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: JIX)

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.

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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