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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aniline Blue
510(k) Number K894045
Device Name MODIFIED POLYCHROME IV STAIN
Applicant
Devetec, Inc.
P.O. Box 10275
Bradenton,  FL  34282
Applicant Contact PRICE, PHD
Correspondent
Devetec, Inc.
P.O. Box 10275
Bradenton,  FL  34282
Correspondent Contact PRICE, PHD
Regulation Number864.1850
Classification Product Code
KFD  
Date Received06/07/1989
Decision Date 07/25/1989
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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