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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K790826
Device Name COAGULATION ARP
Applicant
Helena Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Helena Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.8625
Classification Product Code
JPK  
Date Received04/30/1979
Decision Date 05/31/1979
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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