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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Slide Stainer, Automated
510(k) Number K884258
Device Name VERSABLOT
Applicant
American Bionetics, Inc.
21377 Cabot Blvd.
Hayward,  CA  94545
Applicant Contact FRANK R RUDERMAN
Correspondent
American Bionetics, Inc.
21377 Cabot Blvd.
Hayward,  CA  94545
Correspondent Contact FRANK R RUDERMAN
Regulation Number864.3800
Classification Product Code
KPA  
Date Received10/11/1988
Decision Date 12/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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