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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Parasite Concentration
510(k) Number K931849
Device Name PARAPREP
Applicant
Medastat Scientific Corp.
821 Main St.
Pittsburgh,  PA  15215
Applicant Contact CARMEN V D'AMBROSIO
Correspondent
Medastat Scientific Corp.
821 Main St.
Pittsburgh,  PA  15215
Correspondent Contact CARMEN V D'AMBROSIO
Regulation Number866.2900
Classification Product Code
LKS  
Subsequent Product Code
LIO  
Date Received04/13/1993
Decision Date 12/02/1993
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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