HARDYDISK AST DORIPENEM 10 UG


Device Classification Name

susceptibility test discs, antimicrobial

510(k) Number K080019
Device Name HARDYDISK AST DORIPENEM 10 UG
Applicant
HARDY DIAGNOSTICS
1430 west mccoy ln.
santa maria, 
CA 
93455

Applicant Contact wendy phillips
Correspondent
HARDY DIAGNOSTICS
1430 west mccoy ln.
santa maria, 
CA 
93455

Correspodent Contact wendy phillips
Regulation Number 866.1620
Classification Product Code
JTN  
Date Received 01/03/2008
Decision Date 01/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No