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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Factor Deficient
510(k) Number K902083
Device Name CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
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 Number864.7290
Classification Product Code
GJT  
Date Received05/07/1990
Decision Date 06/15/1990
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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