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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name solution, stabilized enzyme
510(k) Number BK830008
Tradename W.A.R.M.
Device Name Solution, Stabilized Enzyme
Original Applicant
Cooper Biomedical
1230 wilson drive
west chester,  PA  19380
Regulation Number864.9400
Classification Product Code
KSK  
Date Received05/27/1983
Decision Date 06/21/1983
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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