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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864360
Device Name LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE
Applicant
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Applicant Contact WILLIAM C RIDDLE
Correspondent
Trace Scientific , Ltd.
10 Treforest Dr.
Clayton, Vic 3168,  AU
Correspondent Contact WILLIAM C RIDDLE
Date Received11/03/1986
Decision Date 02/06/1987
Decision Substantially Equivalent (SESE)
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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