FDA 510(k)

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

K-Number: K061390 · 2006-07-05

Decision Date2006-07-05

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 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 2006-07-05 under 510(k) number K061390. 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 ENZYME2 CALIBRATOR, MODEL KC320?

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 is a medical device that received FDA 510(k) clearance on 2006-07-05. The listed applicant is Dade Behring, Inc.. The 510(k) number is K061390.

When did DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 receive FDA 510(k) clearance?

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 received FDA 510(k) clearance on 2006-07-05, under 510(k) number K061390.

Who is the listed applicant for DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320?

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 ENZYME2 CALIBRATOR, MODEL KC320?

The FDA product code for DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 is JIX.

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Other records listing Dade Behring, Inc. as applicant

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07 K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

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Related Devices (Code: JIX)

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 Diagnostics K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup K123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories K122398RAPIDPOINT 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.