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FDA 510(k)

DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)

K-Number: K061503 · 2006-06-22

ApplicantDade Behring, Inc.
Decision Date2006-06-22
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) 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 2006-06-22 under 510(k) number K061503. 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 CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)?

DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) is a medical device that received FDA 510(k) clearance on 2006-06-22. The listed applicant is Dade Behring, Inc.. The 510(k) number is K061503.

When did DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) receive FDA 510(k) clearance?

DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) received FDA 510(k) clearance on 2006-06-22, under 510(k) number K061503.

Who is the listed applicant for DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)?

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 CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)?

The FDA product code for DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) 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.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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