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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cholyglycine, Bile Acids
510(k) Number K062503
Device Name CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
Applicant
Catachem, Inc.
955 Connecticut Ave.
Suite 4106
Bridgeport,  CT  06607
Applicant Contact LUIS P LEON
Correspondent
Catachem, Inc.
955 Connecticut Ave.
Suite 4106
Bridgeport,  CT  06607
Correspondent Contact LUIS P LEON
Regulation Number862.1177
Classification Product Code
KWW  
Subsequent Product Codes
JIS   JJX  
Date Received08/25/2006
Decision Date 01/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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