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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K884179
Device Name TURBOX FIBRINOGEN
Applicant
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Applicant Contact MR. G ZAJICEK
Correspondent
Unipath , Ltd.
Norse Rd.
Bedford Mk41 Oqg,  GB
Correspondent Contact MR. G ZAJICEK
Regulation Number864.7340
Classification Product Code
KQJ  
Date Received09/30/1988
Decision Date 12/20/1988
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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