FDA 510(k)

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID

K-Number: K062705 · 2006-10-20

Decision Date2006-10-20

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID 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 2006-10-20 under 510(k) number K062705. 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 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID?

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID is a medical device that received FDA 510(k) clearance on 2006-10-20. The listed applicant is Dade Behring, Inc.. The 510(k) number is K062705.

When did SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID receive FDA 510(k) clearance?

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID received FDA 510(k) clearance on 2006-10-20, under 510(k) number K062705.

Who is the listed applicant for SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID?

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 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID?

The FDA product code for SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID is LON.

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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.