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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Partial Thromboplastin
510(k) Number K992456
Device Name GRADILEIDEN V TEST
Applicant
Gradipore , Ltd.
Lot16 Riverside Corporate Park
35-105 Delhi Rd.
North Ryde,  AU NSW 2113
Applicant Contact RHONDA PILGRIM
Correspondent
Gradipore , Ltd.
Lot16 Riverside Corporate Park
35-105 Delhi Rd.
North Ryde,  AU NSW 2113
Correspondent Contact RHONDA PILGRIM
Regulation Number864.7925
Classification Product Code
GGW  
Date Received07/23/1999
Decision Date 12/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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