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FDA 510(k)

THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050

K-Number: K022108 · 2002-07-25

ApplicantThermo Dma, Inc.
Decision Date2002-07-25
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Dma, Inc.. It received FDA 510(k) clearance on 2002-07-25 under 510(k) number K022108. 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 THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050?

THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 is a medical device that received FDA 510(k) clearance on 2002-07-25. The listed applicant is Thermo Dma, Inc.. The 510(k) number is K022108.

When did THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 receive FDA 510(k) clearance?

THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 received FDA 510(k) clearance on 2002-07-25, under 510(k) number K022108.

Who is the listed applicant for THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050?

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

What is the FDA product code for THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050?

The FDA product code for THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 is JIX.

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Other records listing Thermo Dma, Inc. 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.

K012878THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609K012518TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113K012525THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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