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FDA 510(k)

DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108

K-Number: K052015 · 2005-09-12

ApplicantDade Behring, Inc.
Decision Date2005-09-12
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 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 2005-09-12 under 510(k) number K052015. 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 EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108?

DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 is a medical device that received FDA 510(k) clearance on 2005-09-12. The listed applicant is Dade Behring, Inc.. The 510(k) number is K052015.

When did DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 receive FDA 510(k) clearance?

DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 received FDA 510(k) clearance on 2005-09-12, under 510(k) number K052015.

Who is the listed applicant for DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108?

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 EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108?

The FDA product code for DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 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.

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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.K062182DIMENSION 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.

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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