FDA 510(k)

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

K-Number: K043546 · 2005-01-18

Decision Date2005-01-18

Product CodeCDT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE 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 2005-01-18 under 510(k) number K043546. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE?

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE is a medical device that received FDA 510(k) clearance on 2005-01-18. The listed applicant is Dade Behring, Inc.. The 510(k) number is K043546.

When did DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE receive FDA 510(k) clearance?

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE received FDA 510(k) clearance on 2005-01-18, under 510(k) number K043546.

Who is the listed applicant for DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE?

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 RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE?

The FDA product code for DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE is CDT.

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Related Devices (Code: CDT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.