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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 BK910017
Tradename Control Standard Endotoxin/Pepyrogeneration Valid.
Device Name Kit, Test, Quality Control Kit for Endotoxin
Original Applicant
Assoc. of Cape Cod
p.o. box 224
woods hole,  MA  02543
Classification Product Code
MZL  
Date Received07/16/1991
Decision Date 10/21/1991
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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