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U.S. Department of Health and Human Services

510(K) Premarket Notification

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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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immulite turbo intact pth, model lskptz DIAGNOSTIC PRODUCTS CORP. k992105 07/06/1999
volusion small parts transducer, model s-vnw 5-10, volusion abdominal transducer, model s-vaw 4-7 MEDISON AMERICA, INC. k992155 07/08/1999
omnitip side firing switchable tip with suction/irrigation, model 20371-hp TRIMEDYNE, INC. k992230 07/12/1999
eti-ea-g assay DIASORIN, INC. k992191 07/12/1999
ge logiq 200 md diagnostic ultrasound system GE MEDICAL SYSTEMS, INC. k992208 07/12/1999
at home drug test, model 9175 PHAMATECH k992217 07/13/1999
abca gas isotope ratio mass spectrometer systems PDZ-EUROPA LTD. k992163 07/13/1999
reference material for delta-9-thc-cooh in human urine CONSOLIDATED TECHNOLOGIES, INC. k992151 07/14/1999
tru-touch pf vinyl powder free examination glove MAXXIM MEDICAL k992122 07/15/1999
scimed angiographic catheters SCIMED k992142 07/21/1999

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