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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
510(k) Number K024006
Device Name G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
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 Number864.7360
Classification Product Code
JBF  
Date Received12/04/2002
Decision Date 03/31/2003
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
Recalls CDRH Recalls
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