HARDYDISK OFLOXACIN 5MCG


codes

Device Classification Name

susceptibility test discs, antimicrobial

510(k) Number K000525
Device Name HARDYDISK OFLOXACIN 5MCG
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 02/16/2000
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