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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase, Thymol Blue Monophosphate
510(k) Number K842516
Device Name SANDARE ACID PHOSPHATASE PROCEDURE
Applicant
Sandare Chemical Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sandare Chemical Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1020
Classification Product Code
CJR  
Date Received07/10/1984
Decision Date 08/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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