ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K021445
Device Name ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
Original Applicant
AB BIODISK
dalvagen 10
solna, 

SE

16956

Original Contact anne bolmstrom
Regulation Number 866.1640
Classification Product Code
JWY  
Date Received 05/06/2002
Decision Date 06/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No