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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Fitc, Antigen, Antiserum, Control
510(k) Number K023860
Device Name MICROALBUMIN REAGENT SET AND CALIBRATORS
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 Number866.5040
Classification Product Code
DDZ  
Subsequent Product Code
JIT  
Date Received11/20/2002
Decision Date 04/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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