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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Yeast
510(k) Number K913426
Device Name ALBICANS SURE
Applicant
Jrga Diagnostics
J.R. Greenwood And Associates
27481 Silver Creek Dr.
San Juan Capistrano,  CA  92675
Applicant Contact JAMES R GREENWOOD
Correspondent
Jrga Diagnostics
J.R. Greenwood And Associates
27481 Silver Creek Dr.
San Juan Capistrano,  CA  92675
Correspondent Contact JAMES R GREENWOOD
Regulation Number866.2660
Classification Product Code
JXC  
Date Received08/01/1991
Decision Date 04/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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