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U.S. Department of Health and Human Services

510(K) Premarket Notification
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491 to 500 of 500 Results *
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Device Name
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510(K)
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Decision
Date
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abbott gemstar i.v. infusion pump-7 therapy configuration, abbott gemstar i.v. infusion pump-6 therapy configuration, ab ABBOTT LABORATORIES k994039 12/22/1999
vitros immunodiagnostic products free t3 reagent pack, vitros immunodiagnostic products free t3 calibrators Ortho-Clinical Diagnostics, Inc. k994145 12/22/1999
primus liquid calibrator for ghb/a1c level 1 and level 2 PRIMUS CORP. k994045 12/21/1999
e. histolytica ii TECHLAB, INC. k994101 12/21/1999
lipoprotein (a) spq iii antibody reagent set DIASORIN/AMERICAN STANDARD COMPANIES k994110 12/21/1999
modification to sodem high speed system for neurosurgical use SODEM SYSTEMS k994175 12/21/1999
synthes cervifix system SYNTHES (USA) k994187 12/21/1999
stryker t4 power pack, stryker t4 eight station battery charger, stryker t4 charger module STRYKER INSTRUMENTS k994053 12/20/1999
sonoheart hand-carried echocardiography system SONOSITE,INC. k994096 12/20/1999
at work drug test, model 9145-25c; model 9177-25c PHAMATECH k994093 12/16/1999

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