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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name susceptibility test discs, antimicrobial
510(k) Number K001728
Device Name HARDY DISK CLARITHROMYCIN, 15MCG
Applicant
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Applicant Contact MELISSA TRAYLOR
Correspondent
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Correspondent Contact MELISSA TRAYLOR
Regulation Number866.1620
Classification Product Code
JTN  
Date Received06/07/2000
Decision Date 07/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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