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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 K853239
Device Name HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
Applicant
Haemachem, Inc.
2335 S. Hanley Rd.
St. Louis,  MO  63144
Applicant Contact THYE YIN
Correspondent
Haemachem, Inc.
2335 S. Hanley Rd.
St. Louis,  MO  63144
Correspondent Contact THYE YIN
Regulation Number864.7525
Classification Product Code
KFF  
Date Received08/01/1985
Decision Date 11/05/1985
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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