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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tetraphenyl Borate, Colorimetry, Potassium
510(k) Number K043267
Device Name POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
Applicant
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Applicant Contact P. ARMSTRONG
Correspondent
Randox Laboratories, Ltd.
55 Diamond Rd.
Crumlin,  GB BT29 4QY
Correspondent Contact P. ARMSTRONG
Regulation Number862.1600
Classification Product Code
CEJ  
Subsequent Product Code
JIT  
Date Received11/26/2004
Decision Date 02/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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