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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 K851494
Device Name TWO-STEP ACID FAST BACTERIA STAIN
Applicant
Accra Laboratories, Inc.
P.O. Box 518
Bridgeport,  NJ  08014
Applicant Contact ROBERT C THATCHER
Correspondent
Accra Laboratories, Inc.
P.O. Box 518
Bridgeport,  NJ  08014
Correspondent Contact ROBERT C THATCHER
Regulation Number864.1850
Classification Product Code
JTS  
Date Received04/15/1985
Decision Date 04/29/1985
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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