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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K031539
Device Name HEMOGLOBIN A1C REAGENT SET
Applicant
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Applicant Contact WILLIAM F WALTERS
Correspondent
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Correspondent Contact WILLIAM F WALTERS
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/16/2003
Decision Date 08/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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