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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K844498
Device Name SANDARE ALKALINE PHOSPHATASE PROCEDURE
Applicant
Sandare Chemical Co., Inc.
P.O. Box 3028
Desoto,  TX  75115
Applicant Contact JAMES L SANDERS
Correspondent
Sandare Chemical Co., Inc.
P.O. Box 3028
Desoto,  TX  75115
Correspondent Contact JAMES L SANDERS
Regulation Number862.1050
Classification Product Code
CIO  
Date Received11/20/1984
Decision Date 12/10/1984
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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