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FDA 510(k)

DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND

K-Number: K010061 · 2001-03-14

ApplicantDade Behring, Inc.
Decision Date2001-03-14
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND 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 2001-03-14 under 510(k) number K010061. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND?

DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND is a medical device that received FDA 510(k) clearance on 2001-03-14. The listed applicant is Dade Behring, Inc.. The 510(k) number is K010061.

When did DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND receive FDA 510(k) clearance?

DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND received FDA 510(k) clearance on 2001-03-14, under 510(k) number K010061.

Who is the listed applicant for DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND?

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 CLINICAL CHEMISTRY SYSTEM, MODEL XPAND?

The FDA product code for DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND is CEM.

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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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