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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Platelet Aggregation
510(k) Number K910680
Device Name EPINEPHRINE REAGENT, CAT. NO. 5367
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number864.5700
Classification Product Code
GHR  
Date Received02/15/1991
Decision Date 05/20/1991
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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