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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K813564
Device Name COAG-A-MATE X2
Applicant
General Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
General Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.5400
Classification Product Code
GKP  
Date Received12/22/1981
Decision Date 01/28/1982
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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