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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Susceptibility Test Cards, Antimicrobial
510(k) Number K850347
Device Name API UNISCEPT KB
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
Regulation Number866.1640
Classification Product Code
LTW  
Date Received01/28/1985
Decision Date 03/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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