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FDA 510(k)

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440

K-Number: K082030 · 2008-08-22

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2008-08-22
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K082030. 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 CSAE CALIBRATOR, MODEL KC440?

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K082030.

When did DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 receive FDA 510(k) clearance?

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 received FDA 510(k) clearance on 2008-08-22, under 510(k) number K082030.

Who is the listed applicant for DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440?

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

What is the FDA product code for DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440?

The FDA product code for DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 is DLJ.

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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 ScientificK062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, 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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