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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K841918
Device Name SIGMA PROCED. 245 ALKALINE PHOSPHATASE
Applicant
Sigma Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sigma Diagnostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1050
Classification Product Code
CJE  
Date Received05/09/1984
Decision Date 06/14/1984
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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