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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K851350
Device Name ION 2 REAGENT KI
Applicant
HI CHEM, INC.
231 N. PUENTE ST.
P.O. BOX 1599
BREA,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
HI CHEM, INC.
231 N. PUENTE ST.
P.O. BOX 1599
BREA,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1600
Classification Product Code
CEM  
Date Received04/04/1985
Decision Date 04/29/1985
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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