FDA 510(k)

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

K-Number: K101425 · 2010-09-10

Decision Date2010-09-10

Product CodeLRG

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2010-09-10 under 510(k) number K101425. 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 DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES?

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES is a medical device that received FDA 510(k) clearance on 2010-09-10. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K101425.

When did MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES receive FDA 510(k) clearance?

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES received FDA 510(k) clearance on 2010-09-10, under 510(k) number K101425.

Who is the listed applicant for MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES?

The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES?

The FDA product code for MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES is 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.