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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name media and components, synthetic cell and tissue culture
510(k) Number K861996
Device Name DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM
Original Applicant
HAZLETON RESEARCH PRODUCTS, INC.
box 7200
denver,  PA  17517
Original Contact noel, ph.d.
Regulation Number864.2220
Classification Product Code
KIT  
Date Received05/23/1986
Decision Date 06/09/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
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