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FDA 510(k)

BAYER SPECIAL CHEMISTRY CALIBRATORS

K-Number: K033380 · 2003-12-16

ApplicantBayer Diagnostics Corp.
Decision Date2003-12-16
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BAYER SPECIAL CHEMISTRY CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Diagnostics Corp.. It received FDA 510(k) clearance on 2003-12-16 under 510(k) number K033380. 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 BAYER SPECIAL CHEMISTRY CALIBRATORS?

BAYER SPECIAL CHEMISTRY CALIBRATORS is a medical device that received FDA 510(k) clearance on 2003-12-16. The listed applicant is Bayer Diagnostics Corp.. The 510(k) number is K033380.

When did BAYER SPECIAL CHEMISTRY CALIBRATORS receive FDA 510(k) clearance?

BAYER SPECIAL CHEMISTRY CALIBRATORS received FDA 510(k) clearance on 2003-12-16, under 510(k) number K033380.

Who is the listed applicant for BAYER SPECIAL CHEMISTRY CALIBRATORS?

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

What is the FDA product code for BAYER SPECIAL CHEMISTRY CALIBRATORS?

The FDA product code for BAYER SPECIAL CHEMISTRY CALIBRATORS is JIX.

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Other records listing Bayer Diagnostics Corp. 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.

K033379BAYER SPECIAL CHEMISTRY CONTROLSK033007BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEMK031857ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYK022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMK030452BAYER LIGAND PLUS 1, 2, 3 CONTROLSK023840ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

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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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