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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K970933
Device Name AUTO HDL CHOLESTEROL CALIBRATOR
Applicant
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Applicant Contact WILLIAM F WALTERS, JR.
Correspondent
POINTE SCIENTIFIC, INC.
1025 JOHN A. PAPALAS DR.
LINCOLN PARK,  MI  48146
Correspondent Contact WILLIAM F WALTERS, JR.
Regulation Number862.1150
Classification Product Code
JIS  
Date Received03/13/1997
Decision Date 05/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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