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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 centrifuge, cell-washing, automated for immuno-hematology
510(k) Number BK920019
Tradename Inverness Automated Antibody Screening System
Device Name Centrifuge, Cell-Washing, Automated for Immunohematology
Original Applicant
I. B. G. Systems Inc.
p.o. box 5306
laytonsville,  MD  20882
Regulation Number864.9285
Classification Product Code
KSN  
Date Received06/29/1992
Decision Date 03/26/1993
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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