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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 K840211
Device Name FIBRI-PREST AUTOMATE HA34
Applicant
Wellcome Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wellcome Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7340
Classification Product Code
KQJ  
Date Received01/19/1984
Decision Date 03/02/1984
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
Recalls CDRH Recalls
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