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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Collection, Capillary Blood
510(k) Number K885138
Device Name CAPILLARY TUBE, BLOOD COLLECTION
Applicant
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Applicant Contact TERESA R MCCLEERY
Correspondent
Coeur Laboratories, Inc.
5301 Depature Dr.
Raleigh,  NC  27604
Correspondent Contact TERESA R MCCLEERY
Regulation Number864.6150
Classification Product Code
GIO  
Date Received12/15/1988
Decision Date 02/07/1989
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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