HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939


Device Classification Name

susceptibility test discs, antimicrobial

510(k) Number K103538
Device Name HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
Applicant
HARDY DIAGNOSTICS
1430 west mccoy ln.
santa maria, 
CA 
93455

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

Correspodent Contact wendy hadley
Regulation Number 866.1620
Classification Product Code
JTN  
Date Received 12/02/2010
Decision Date 12/17/2010
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