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FDA 510(k)

DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM

K-Number: K070346 · 2007-07-18

ApplicantDade Behring, Inc.
Decision Date2007-07-18
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM 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 2007-07-18 under 510(k) number K070346. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM?

DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-07-18. The listed applicant is Dade Behring, Inc.. The 510(k) number is K070346.

When did DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM receive FDA 510(k) clearance?

DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM received FDA 510(k) clearance on 2007-07-18, under 510(k) number K070346.

Who is the listed applicant for DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM?

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 DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM?

The FDA product code for DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM is LON.

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Official Source

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