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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 K001462
Device Name CARESIDE HEMOGLOBIN
Applicant
Careside, Inc.
6100 Bristol Pkwy.
Culver City,  CA  90230
Applicant Contact KENNETH B ASARCH
Correspondent
Careside, Inc.
6100 Bristol Pkwy.
Culver City,  CA  90230
Correspondent Contact KENNETH B ASARCH
Regulation Number864.7500
Classification Product Code
KHG  
Date Received05/10/2000
Decision Date 08/21/2000
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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