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FDA 510(k)

MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN

K-Number: K063299 · 2006-11-27

ApplicantDade Behring, Inc.
Decision Date2006-11-27
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN 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 2006-11-27 under 510(k) number K063299. 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-CLARITHROMYCIN?

MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN is a medical device that received FDA 510(k) clearance on 2006-11-27. The listed applicant is Dade Behring, Inc.. The 510(k) number is K063299.

When did MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN receive FDA 510(k) clearance?

MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN received FDA 510(k) clearance on 2006-11-27, under 510(k) number K063299.

Who is the listed applicant for MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN?

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-CLARITHROMYCIN?

The FDA product code for MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN is LRG.

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Related Devices (Code: LRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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