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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Fibrinogen
510(k) Number K881685
Device Name FIBRINOGENTEST-O
Applicant
Diatech, Inc.
P.O. Box 15700
Fort Lauderdale,  FL  33318
Applicant Contact L WILBOURN
Correspondent
Diatech, Inc.
P.O. Box 15700
Fort Lauderdale,  FL  33318
Correspondent Contact L WILBOURN
Regulation Number864.7340
Classification Product Code
GIS  
Date Received04/19/1988
Decision Date 08/09/1988
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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