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FDA 510(k)

MICROSCAN(R) MICROSTREP PLUS(R)

K-Number: K111677 · 2011-08-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2011-08-04
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN(R) MICROSTREP PLUS(R) 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 2011-08-04 under 510(k) number K111677. 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(R) MICROSTREP PLUS(R)?

MICROSCAN(R) MICROSTREP PLUS(R) is a medical device that received FDA 510(k) clearance on 2011-08-04. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K111677.

When did MICROSCAN(R) MICROSTREP PLUS(R) receive FDA 510(k) clearance?

MICROSCAN(R) MICROSTREP PLUS(R) received FDA 510(k) clearance on 2011-08-04, under 510(k) number K111677.

Who is the listed applicant for MICROSCAN(R) MICROSTREP PLUS(R)?

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(R) MICROSTREP PLUS(R)?

The FDA product code for MICROSCAN(R) MICROSTREP PLUS(R) is LRG.

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Related Devices (Code: LRG)

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.

K191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK110583SENSITITRE OPTIREADTrek Diagnostic Systems, Ltd.K103532AUTOREADER 2Trek Diagnostic SystemsK111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSiemens Healthcare Diagnostics, Inc.K101425MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIESSiemens Healthcare Diagnostics

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.

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