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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K040391
Device Name TOTAL BILIRUBIN REAGENT SET
Applicant
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Applicant Contact RON JAMISON
Correspondent
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Correspondent Contact RON JAMISON
Regulation Number862.1110
Classification Product Code
CIG  
Date Received02/17/2004
Decision Date 06/02/2004
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
Recalls CDRH Recalls
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