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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coulometric, Chloride
510(k) Number K873127
Device Name CHLORIDE REAGENT KIT
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 Number862.1170
Classification Product Code
JFS  
Date Received08/10/1987
Decision Date 10/23/1987
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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