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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Screening, For D Positive Fetal Rbc'S
510(k) Number K980314
Device Name FETAL D TECTION KIT
Applicant
Biopool Intl., Inc.
1230 Wilson Dr.
West Chester,  PA  19380
Applicant Contact PETER L MINETTI
Correspondent
Biopool Intl., Inc.
1230 Wilson Dr.
West Chester,  PA  19380
Correspondent Contact PETER L MINETTI
Regulation Number864.7455
Classification Product Code
LIM  
Date Received01/27/1998
Decision Date 04/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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