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FDA 510(k)

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN

K-Number: K981199 · 1998-11-18

ApplicantDade Microscan, Inc.
Decision Date1998-11-18
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Dade Microscan, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K981199. 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 PANELS , ESBL SCREEN?

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Dade Microscan, Inc.. The 510(k) number is K981199.

When did MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN receive FDA 510(k) clearance?

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN received FDA 510(k) clearance on 1998-11-18, under 510(k) number K981199.

Who is the listed applicant for MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN?

The FDA 510(k) record lists Dade Microscan, Inc. 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 PANELS , ESBL SCREEN?

The FDA product code for MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN is LRG.

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Other records listing Dade Microscan, Inc. as applicant

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.

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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.

K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK110583SENSITITRE OPTIREADTrek Diagnostic Systems, Ltd.K103532AUTOREADER 2Trek Diagnostic SystemsK111677MICROSCAN(R) MICROSTREP PLUS(R)Siemens Healthcare Diagnostics, Inc.K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSiemens Healthcare Diagnostics, Inc.

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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