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FDA 510(k)

DIMENSION DRUG CALIBRATOR, MODEL DC22B

K-Number: K011035 · 2001-06-14

ApplicantDade Behring, Inc.
Decision Date2001-06-14
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION DRUG CALIBRATOR, MODEL DC22B 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 2001-06-14 under 510(k) number K011035. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION DRUG CALIBRATOR, MODEL DC22B?

DIMENSION DRUG CALIBRATOR, MODEL DC22B is a medical device that received FDA 510(k) clearance on 2001-06-14. The listed applicant is Dade Behring, Inc.. The 510(k) number is K011035.

When did DIMENSION DRUG CALIBRATOR, MODEL DC22B receive FDA 510(k) clearance?

DIMENSION DRUG CALIBRATOR, MODEL DC22B received FDA 510(k) clearance on 2001-06-14, under 510(k) number K011035.

Who is the listed applicant for DIMENSION DRUG CALIBRATOR, MODEL DC22B?

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, MODEL DC22B?

The FDA product code for DIMENSION DRUG CALIBRATOR, MODEL DC22B is JIX.

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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: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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