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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Hematology
510(k) Number K882873
Device Name FIELDTEX HEMATOXYLIN
Applicant
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Applicant Contact FELDMAN, M.S.
Correspondent
Anatech, Ltd.
1020 Harts Lake Rd.
Battle Creek,  MI  49015
Correspondent Contact FELDMAN, M.S.
Regulation Number864.1850
Classification Product Code
KQC  
Date Received07/11/1988
Decision Date 07/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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