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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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osteomark ntx point of care prescription home use OSTEX INTL., INC. k011052 07/30/2001
opi band ORTHOMERICA PRODUCTS, INC. k001167 07/07/2000
vitro chemistry products eco2 slide & calibrator kit 2 Ortho-Clinical Diagnostics, Inc. k001133 04/24/2000
vitros chemistry products ast slide and chemistry products calibrator kit 3 Ortho-Clinical Diagnostics, Inc. k001679 06/28/2000
microstream external battery charger ORIDION MEDICAL 1987 LTD. k002163 01/11/2001
pccr digital imaging device OREX COMPUTED RADIOGRAPHY LTD k003256 11/08/2000
cocaine metabolite intercept micro-plate eia ORASURE TECHNOLOGIES, INC. k001197 05/11/2000
intercept oral fluid drug test oral specimen collection device, model 503-xxxx ORASURE TECHNOLOGIES, INC. k011057 06/06/2001
optivu hdvd system OPTIMIZE, INC. k001169 05/16/2000
ois-stand alone diagnostic ultrasound system OPTIMAL IMAGING SYSTEMS, INC. k000034 02/24/2000

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