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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K844567
Device Name TITERTEK TWINREADER 78-630-00
Applicant
FLOW LABORATORIES, INC.
7655 OLD SPRINGHOUSE RD.
MCLEAN,  VA  22102
Applicant Contact JOY F POPPE
Correspondent
FLOW LABORATORIES, INC.
7655 OLD SPRINGHOUSE RD.
MCLEAN,  VA  22102
Correspondent Contact JOY F POPPE
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received11/23/1984
Decision Date 03/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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