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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 K843732
Device Name API UNISCEPT MIC
Applicant
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803
Applicant Contact SUSAN D TIEDY
Correspondent
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803
Correspondent Contact SUSAN D TIEDY
Classification Product Code
LTD  
Date Received09/24/1984
Decision Date 10/24/1984
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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