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FDA 510(k)

DIMENSION DRUG CALIBRATOR II, MODEL DC49C

K-Number: K032574 · 2003-10-06

ApplicantDade Behring, Inc.
Decision Date2003-10-06
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIMENSION DRUG CALIBRATOR II, MODEL DC49C 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 2003-10-06 under 510(k) number K032574. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION DRUG CALIBRATOR II, MODEL DC49C?

DIMENSION DRUG CALIBRATOR II, MODEL DC49C is a medical device that received FDA 510(k) clearance on 2003-10-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K032574.

When did DIMENSION DRUG CALIBRATOR II, MODEL DC49C receive FDA 510(k) clearance?

DIMENSION DRUG CALIBRATOR II, MODEL DC49C received FDA 510(k) clearance on 2003-10-06, under 510(k) number K032574.

Who is the listed applicant for DIMENSION DRUG CALIBRATOR II, MODEL DC49C?

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 DRUG CALIBRATOR II, MODEL DC49C?

The FDA product code for DIMENSION DRUG CALIBRATOR II, MODEL DC49C is DKB.

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Other records listing Dade Behring, Inc. as applicant

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Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)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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