FDA 510(k)

MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)

K-Number: K020168 · 2002-02-06

Decision Date2002-02-06

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/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 2002-02-06 under 510(k) number K020168. 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 MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)?

MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) is a medical device that received FDA 510(k) clearance on 2002-02-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K020168.

When did MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) receive FDA 510(k) clearance?

MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) received FDA 510(k) clearance on 2002-02-06, under 510(k) number K020168.

Who is the listed applicant for MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/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 SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)?

The FDA product code for MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) 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.