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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 supplies, blood-bank
510(k) Number BK860031
Tradename Hema-Bath
Device Name Supplies, Blood-Bank
Original Applicant
Lab-Line Instruments, Inc.
15th and bloomingdale avenues
melrose park,  IL  60160
Regulation Number864.9050
Classification Product Code
KSS  
Date Received09/16/1986
Decision Date 03/02/1987
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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