FDA 510(k) Application Details - K843839

Device Classification Name Lead, Atomic Absorption

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510(K) Number K843839
Device Name Lead, Atomic Absorption
Applicant TRI-TECH, INC.
5120 REVERE ROAD
DURHAM, NC US
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Contact JAY W WALKER
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Regulation Number 862.3550

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Classification Product Code DOF
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Date Received 10/01/1984
Decision Date 01/03/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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