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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lead, Atomic Absorption
510(k) Number K843839
Device Name STAT/PB REAGENT
Applicant
Tri-Tech, Inc.
5120 Revere Rd.
Durham,  NC  27713 -
Applicant Contact JAY W WALKER
Correspondent
Tri-Tech, Inc.
5120 Revere Rd.
Durham,  NC  27713 -
Correspondent Contact JAY W WALKER
Regulation Number862.3550
Classification Product Code
DOF  
Date Received10/01/1984
Decision Date 01/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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