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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumocystis Carinii
510(k) Number K923349
Device Name FUNGI FLUOR KIT
Applicant
Polysciences, Inc.
400 Valley Rd.
Warrington,  PA  18976
Applicant Contact BARBARA WAGGETT
Correspondent
Polysciences, Inc.
400 Valley Rd.
Warrington,  PA  18976
Correspondent Contact BARBARA WAGGETT
Regulation Number866.3780
Classification Product Code
LYF  
Date Received07/08/1992
Decision Date 10/20/1992
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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