MRSA-SCREEN


Device Classification Name

system,test,genotypic detection,resistant markers,staphylococcus colonies

510(k) Number K011400
Device Name MRSA-SCREEN
Original Applicant
DENKA SEIKEN’S
3-4-2 nihonbashi
kayabacho, chuo-ku
tokyo, 

JP

103-0025

Original Contact kevin mangan
Regulation Number 866.1640
Classification Product Code
MYI  
Date Received 05/07/2001
Decision Date 03/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No