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FDA 510(k)

MRSA-SCREEN

K-Number: K011400 · 2002-03-27

ApplicantDenka Seiken'S
Decision Date2002-03-27
Product CodeMYI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MRSA-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Denka Seiken'S. It received FDA 510(k) clearance on 2002-03-27 under 510(k) number K011400. The device is classified under product code MYI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRSA-SCREEN?

MRSA-SCREEN is a medical device that received FDA 510(k) clearance on 2002-03-27. The listed applicant is Denka Seiken'S. The 510(k) number is K011400.

When did MRSA-SCREEN receive FDA 510(k) clearance?

MRSA-SCREEN received FDA 510(k) clearance on 2002-03-27, under 510(k) number K011400.

Who is the listed applicant for MRSA-SCREEN?

The FDA 510(k) record lists Denka Seiken'S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRSA-SCREEN?

The FDA product code for MRSA-SCREEN is MYI.

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Other records listing Denka Seiken'S 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.

K013359LP(A)-LATEX SEIKEN ASSAY KITK011958CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KITK981734VTEC-RPLA SEIKEN

Related Devices (Code: MYI)

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.

K121905ALERE PBP2A TESTAlere Scarborough, Inc.K090301BINAXNOW PBP2A TEST, MODEL 890-000Binax, Inc.K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000Binax, Inc.K062864MASTALEX -MRSA, MODEL RST501Mast Group , Ltd.K011710OXOID PBP2 1 LATEX AGGLUTINATION TESTOxoid , Ltd.K010858VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTIONId Biomedical Corp.

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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