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FDA 510(k)

MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)

K-Number: K063065 · 2006-10-27

ApplicantDade Behring, Inc.
Decision Date2006-10-27
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/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 2006-10-27 under 510(k) number K063065. 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 MEROPENEM (0.03-4MCG/ML)?

MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Dade Behring, Inc.. The 510(k) number is K063065.

When did MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) receive FDA 510(k) clearance?

MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) received FDA 510(k) clearance on 2006-10-27, under 510(k) number K063065.

Who is the listed applicant for MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/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 MEROPENEM (0.03-4MCG/ML)?

The FDA product code for MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/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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