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FDA 510(k)

CALIBRATION PACK, MODELS A9100-101S AND A9100-103S

K-Number: K023792 · 2003-01-31

ApplicantThermo Orion
Decision Date2003-01-31
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALIBRATION PACK, MODELS A9100-101S AND A9100-103S is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Orion. It received FDA 510(k) clearance on 2003-01-31 under 510(k) number K023792. 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 CALIBRATION PACK, MODELS A9100-101S AND A9100-103S?

CALIBRATION PACK, MODELS A9100-101S AND A9100-103S is a medical device that received FDA 510(k) clearance on 2003-01-31. The listed applicant is Thermo Orion. The 510(k) number is K023792.

When did CALIBRATION PACK, MODELS A9100-101S AND A9100-103S receive FDA 510(k) clearance?

CALIBRATION PACK, MODELS A9100-101S AND A9100-103S received FDA 510(k) clearance on 2003-01-31, under 510(k) number K023792.

Who is the listed applicant for CALIBRATION PACK, MODELS A9100-101S AND A9100-103S?

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

What is the FDA product code for CALIBRATION PACK, MODELS A9100-101S AND A9100-103S?

The FDA product code for CALIBRATION PACK, MODELS A9100-101S AND A9100-103S is JIX.

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Other records listing Thermo Orion 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.

K844559MODEL 1020 NA+/K+(SODIUM/POTASSIUM)ANALYZER MULTIK821822MODEL 1020 NA/K ANALYZER

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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