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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K871294
Device Name ACU-PREG-AL SLIDE TEST
Applicant
Papibris Scientific, Inc.
P.O. Box 381751
Miami,  FL  33238
Applicant Contact DANIEL BRISARD
Correspondent
Papibris Scientific, Inc.
P.O. Box 381751
Miami,  FL  33238
Correspondent Contact DANIEL BRISARD
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received03/31/1987
Decision Date 05/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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