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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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e.n.s.i. syringe Tri-Ject Intl. Corp. k000572 02/24/2000
immulite phenytoin, immulite 2000 phenytoin, catalog # lkpn1, lkpn5 & l2kpn2, l2kpn6 Diagnostic Products Corp. k000006 02/28/2000
immulite carbamazepine, immulite 2000 carbamazepine, catalog # lkcb1, lkcb5 & l2kcb2, l2kcb6 Diagnostic Products Corp. k000007 02/28/2000
modified hydrophilic coated guidewire Lake Region Mfg., Inc. k000011 03/01/2000
immulite valproic acid, immulite 2000 valproic acid, catalog # lkva1, lkva5 & l2kva2, l2kva6 Diagnostic Products Corp. k000005 03/03/2000
immulite phenobarbital, models lkpb1, lkpb5 Diagnostic Products Corp. k000012 03/03/2000
modofication to vitro immunodiagnostic products psa reagent pack, vitro immunodiagnostic products psa calibrators Ortho-Clinical Diagnostics, Inc. k000566 03/09/2000
ultrasound scanner type 2102 B & K Medical A/S k000567 03/09/2000
spiral radius rodding system United States Surgical, A Division of Tyco Healthc k000009 03/10/2000
global advantage extended humeral head DePuy Orthopaedics, Inc. k000575 03/10/2000

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