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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
510(k) Number K890996
Device Name LD1 ISOENZYME REAGENT KIT
Applicant
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Applicant Contact P. J RUTHVEN
Correspondent
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Correspondent Contact P. J RUTHVEN
Regulation Number862.1445
Classification Product Code
JGF  
Date Received02/27/1989
Decision Date 05/05/1989
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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