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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K032874
Device Name HBA SPERM-HYALURONAN BINDING ASSAY
Applicant
BIOCOAT, INC.
455 PENNSYLVANIA AVE.
FORT WASHINGTON,  PA  19034
Applicant Contact JAMES B JOHNSTON
Correspondent
BIOCOAT, INC.
455 PENNSYLVANIA AVE.
FORT WASHINGTON,  PA  19034
Correspondent Contact JAMES B JOHNSTON
Regulation Number864.5220
Classification Product Code
POV  
Date Received09/15/2003
Decision Date 11/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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