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FDA 510(k)

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

K-Number: K062182 · 2006-09-14

ApplicantDade Behring, Inc.
Decision Date2006-09-14
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 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 2006-09-14 under 510(k) number K062182. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520?

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 is a medical device that received FDA 510(k) clearance on 2006-09-14. The listed applicant is Dade Behring, Inc.. The 510(k) number is K062182.

When did DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 receive FDA 510(k) clearance?

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 received FDA 510(k) clearance on 2006-09-14, under 510(k) number K062182.

Who is the listed applicant for DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520?

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 ECSTASY CALIBRATOR, MODEL KC520?

The FDA product code for DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 is DLJ.

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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: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, Inc.K060503DIMENSION TACR CALIBRATOR, MODEL DC107Dade Behring, 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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