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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sampler, Amniotic Fluid (Amniocentesis Tray)
510(k) Number K914419
Device Name AMNIOTEST(TM)
Applicant
Pro-Lab, Inc.
76 Glengarry Ave.
Toronto
Ontario Canada M5m 1c9,  CA
Applicant Contact JOACHIM SPARKUHL
Correspondent
Pro-Lab Diagnostics USA
21 Cypress Blvd., Suite 1070
Round Rock,  TX  78665
Correspondent Contact Robert J Rae
Regulation Number884.1550
Classification Product Code
HIO  
Date Received10/03/1991
Decision Date 09/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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