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FDA 510(k)

ATAC CALIBRATOR

K-Number: K030621 · 2003-03-19

ApplicantElan Diagnostics
Decision Date2003-03-19
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2003-03-19 under 510(k) number K030621. 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 ATAC CALIBRATOR?

ATAC CALIBRATOR is a medical device that received FDA 510(k) clearance on 2003-03-19. The listed applicant is Elan Diagnostics. The 510(k) number is K030621.

When did ATAC CALIBRATOR receive FDA 510(k) clearance?

ATAC CALIBRATOR received FDA 510(k) clearance on 2003-03-19, under 510(k) number K030621.

Who is the listed applicant for ATAC CALIBRATOR?

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

What is the FDA product code for ATAC CALIBRATOR?

The FDA product code for ATAC CALIBRATOR is JIX.

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Other records listing Elan Diagnostics 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.

K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030014ATAC TOTAL BILIRUBIN REAGENTK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030010ATAC PAK MAGNESIUM REAGENTK030015ATAC PAK PHOSPHORUS REAGENTK030006ATAC PAK ALBUMIN REAGENT

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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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