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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K952667
Device Name CHROM Z-HEPARIN, CAT. NO 5242
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 Number864.7525
Classification Product Code
KFF  
Date Received06/12/1995
Decision Date 02/14/1996
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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