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FDA 510(k)

MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)

K-Number: K063053 · 2006-10-26

ApplicantDade Behring, Inc.
Decision Date2006-10-26
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) 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 2006-10-26 under 510(k) number K063053. The device is classified under product code LRG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)?

MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) is a medical device that received FDA 510(k) clearance on 2006-10-26. The listed applicant is Dade Behring, Inc.. The 510(k) number is K063053.

When did MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) receive FDA 510(k) clearance?

MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) received FDA 510(k) clearance on 2006-10-26, under 510(k) number K063053.

Who is the listed applicant for MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)?

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 MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)?

The FDA product code for MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) is LRG.

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Related Devices (Code: LRG)

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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.

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