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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solution, copper sulfate for specific gravity determinations
510(k) Number BK840018
Tradename Copper Sulfate Solution ( for women)
Device Name Solution, Copper Sulfate for Specific Gravity Determination
Original Applicant
EK Industries, Inc.
411 kay avenue
addison,  IL  60101
Regulation Number864.9320
Classification Product Code
KSL  
Date Received08/01/1984
Decision Date 12/11/1984
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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