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FDA 510(k)

MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS

K-Number: K131275 · 2013-11-08

ApplicantSiemens Helathcare Diagnostics, Inc.
Decision Date2013-11-08
Product CodeLTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Helathcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2013-11-08 under 510(k) number K131275. 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-POSTIVE MIC/COMBO PANELS?

MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS is a medical device that received FDA 510(k) clearance on 2013-11-08. The listed applicant is Siemens Helathcare Diagnostics, Inc.. The 510(k) number is K131275.

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

MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS received FDA 510(k) clearance on 2013-11-08, under 510(k) number K131275.

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

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

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

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

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Other records listing Siemens Helathcare Diagnostics, Inc. as applicant

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Related Devices (Code: LTT)

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.

K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc.K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc.K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc.K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc.K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc.

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.

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