FDA 510(k)

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE

K-Number: K123933 · 2013-03-14

ApplicantSiemens Healthcare Diagnostics, Inc.

Decision Date2013-03-14

Product CodeLTT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K123933. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE?

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K123933.

When did MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE receive FDA 510(k) clearance?

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE received FDA 510(k) clearance on 2013-03-14, under 510(k) number K123933.

Who is the listed applicant for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE?

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

What is the FDA product code for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE?

The FDA product code for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE is LTT.

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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.