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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Enterobacteriaceae
510(k) Number K924814
Device Name API 20E/UNISCEPT 20E
Applicant
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803 -
Applicant Contact VALERIE L VARGO
Correspondent
Analytical Products, Inc.
200 Express St.
Plainview,  NY  11803 -
Correspondent Contact VALERIE L VARGO
Regulation Number866.2660
Classification Product Code
JSS  
Date Received09/25/1992
Decision Date 03/11/1993
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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