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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K882587
Device Name A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
Applicant
A-Kem, Inc.
P.O. Box 1589
82 Industrial E.
Clifton,  NJ  07015
Applicant Contact STEVEN LEE
Correspondent
A-Kem, Inc.
P.O. Box 1589
82 Industrial E.
Clifton,  NJ  07015
Correspondent Contact STEVEN LEE
Regulation Number862.1035
Classification Product Code
CIX  
Date Received06/23/1988
Decision Date 08/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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