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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, test, quality control for endotoxin
510(k) Number BK860039
Tradename Toxinometer ET-201
Device Name Kit, Test, Quality Control Kit for Endotoxin
Original Applicant
Wako Chemicals, USA, Inc.
12300 ford road, suite 130
dallas,  TX  75234
Classification Product Code
MZL  
Date Received10/01/1986
Decision Date 02/10/1987
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
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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