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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 K863104
Device Name TOTAL HEMOGLOBIN
Applicant
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Applicant Contact DI PIETRO
Correspondent
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Correspondent Contact DI PIETRO
Regulation Number864.7500
Classification Product Code
KHG  
Date Received08/14/1986
Decision Date 09/04/1986
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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