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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 K970120
Device Name BILE ACIDS REAGENT SET
Applicant
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Applicant Contact ANDREW REAMS
Correspondent
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Correspondent Contact ANDREW REAMS
Regulation Number862.1177
Classification Product Code
KWW  
Date Received01/14/1997
Decision Date 03/24/1997
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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