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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K842915
Device Name SULFOSALICYLIC ACID, 3% W/V
Applicant
E K Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
E K Ind., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1645
Classification Product Code
JIQ  
Date Received07/25/1984
Decision Date 08/10/1984
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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