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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K922926
Device Name API UNISCEPT KB/TYPE 2 AND 3
Applicant
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803 -
Applicant Contact ANN W SISALLI
Correspondent
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803 -
Correspondent Contact ANN W SISALLI
Regulation Number866.1640
Classification Product Code
JWY  
Date Received06/17/1992
Decision Date 10/13/1992
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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