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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Paraquat Assay
510(k) Number K843612
Device Name MODIFICATION OF ABL MIC-10 PRECEPT SYS
Applicant
Austin Biological Laboratories
6620 Manor Rd.
Austin,  TX  78723 -
Applicant Contact REX L BRADLEY
Correspondent
Austin Biological Laboratories
6620 Manor Rd.
Austin,  TX  78723 -
Correspondent Contact REX L BRADLEY
Classification Product Code
LTD  
Date Received09/13/1984
Decision Date 02/19/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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