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FDA 510(k)

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

K-Number: K061750 · 2006-08-11

ApplicantDade Behring, Inc.
Decision Date2006-08-11
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-08-11 under 510(k) number K061750. 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 DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220?

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 is a medical device that received FDA 510(k) clearance on 2006-08-11. The listed applicant is Dade Behring, Inc.. The 510(k) number is K061750.

When did DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 receive FDA 510(k) clearance?

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 received FDA 510(k) clearance on 2006-08-11, under 510(k) number K061750.

Who is the listed applicant for DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220?

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

What is the FDA product code for DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220?

The FDA product code for DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 is JIX.

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Other records listing Dade Behring, 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.

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYSTK081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMK071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

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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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