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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Microbiologic
510(k) Number K870988
Device Name PRICE'S ACID-FAST 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
JTS  
Date Received03/11/1987
Decision Date 03/30/1987
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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