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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 K872916
Device Name HISTOMATIC SLIDE STAINER, CODE-ON VERSION
Applicant
FISHER SCIENTIFIC CO., LLC.
1410 WAYNE AVE.
INDIANA,  PA  15701
Applicant Contact DEAN C HOBSON
Correspondent
FISHER SCIENTIFIC CO., LLC.
1410 WAYNE AVE.
INDIANA,  PA  15701
Correspondent Contact DEAN C HOBSON
Regulation Number864.3800
Classification Product Code
KPA  
Date Received07/24/1987
Decision Date 09/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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