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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K802117
Device Name FIBRI QUIK
Applicant
General Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
General Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7875
Classification Product Code
GJA  
Date Received09/04/1980
Decision Date 09/26/1980
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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