HARDYDISK, SULFA/TRIMETH


Device Classification Name

susceptibility test discs, antimicrobial

510(k) Number K000271
Device Name HARDYDISK, SULFA/TRIMETH
Original Applicant
HARDY DIAGNOSTICS
1430 west mccoy ln.
santa maria, 
CA 
93455

Original Contact melissa m traylor
Regulation Number 866.1620
Classification Product Code
JTN  
Date Received 01/28/2000
Decision Date 04/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No