ETEST DORIPENEM – ANTIMICROBIAL SUSCEPTIBILITY TEST – MIC AT 0.002-32 UG/ML


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K081325
Device Name ETEST DORIPENEM – ANTIMICROBIAL SUSCEPTIBILITY TEST – MIC AT 0.002-32 UG/ML
Applicant
AB BIODISK
dalvagen 10
solna, 

SE

16956

Applicant Contact anette engelhardt
Correspondent
AB BIODISK
dalvagen 10
solna, 

SE

16956

Correspodent Contact anette engelhardt
Regulation Number 866.1640
Classification Product Code
JWY  
Date Received 05/12/2008
Decision Date 07/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No