MRSA-SCREEN— 510(k) K011400

Substantially Equivalent

Denka Seiken'S

FDA 510(k) clearance K011400 for MRSA-SCREEN, Substantially Equivalent on 2002-03-27. Applicant: Denka Seiken'S. Device class: 2.

Clearance details

Applicant: Denka Seiken'S
Product code: Code MYI
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2001-05-07
Decision date: 2002-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.