ETEST LINEZOLID


Device Classification Name

discs, elution

510(k) Number K002139
Device Name ETEST LINEZOLID
Original Applicant
AB BIODISK
dalvagen 10
solna, 

SE

16956

Original Contact anne bolmstorm
Regulation Number 866.1620
Classification Product Code
LTX  
Date Received 07/17/2000
Decision Date 11/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No