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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Whole Blood Hemoglobin Determination
510(k) Number K851432
Device Name HEMOGLOBIN
Applicant
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Applicant Contact JANUSZ M SZYSZKO
Correspondent
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Correspondent Contact JANUSZ M SZYSZKO
Regulation Number864.7500
Classification Product Code
KHG  
Date Received04/10/1985
Decision Date 07/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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