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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 K811780
Device Name ACCRA-LAB GRAM STAIN SET 55760
Applicant
Accra Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Accra Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.1850
Classification Product Code
JTS  
Date Received06/23/1981
Decision Date 07/27/1981
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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