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FDA 510(k)

HEMOSIL CALIBRATION PLASMA

K-Number: K041905 · 2004-09-28

ApplicantInstrumentation Laboratory CO
Decision Date2004-09-28
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEMOSIL CALIBRATION PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2004-09-28 under 510(k) number K041905. 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 HEMOSIL CALIBRATION PLASMA?

HEMOSIL CALIBRATION PLASMA is a medical device that received FDA 510(k) clearance on 2004-09-28. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K041905.

When did HEMOSIL CALIBRATION PLASMA receive FDA 510(k) clearance?

HEMOSIL CALIBRATION PLASMA received FDA 510(k) clearance on 2004-09-28, under 510(k) number K041905.

Who is the listed applicant for HEMOSIL CALIBRATION PLASMA?

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

What is the FDA product code for HEMOSIL CALIBRATION PLASMA?

The FDA product code for HEMOSIL CALIBRATION PLASMA is JIX.

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Other records listing Instrumentation Laboratory CO as applicant

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K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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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