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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K896474
Device Name RESUBMITTED FECATWIN SENSITIVE - FECA-EIA
Applicant
Labsystems, Inc.
Pulttitie 8
00880 Helsinki
Finland,  FI
Applicant Contact PAIVI SORMUNEN
Correspondent
Labsystems, Inc.
Pulttitie 8
00880 Helsinki
Finland,  FI
Correspondent Contact PAIVI SORMUNEN
Regulation Number864.6550
Classification Product Code
KHE  
Date Received11/13/1989
Decision Date 01/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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