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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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asyra GALLOWAY TECHNOLOGIES, LLC k023355 06/24/2003
at home drug test, model 9063 PHAMATECH k994237 12/30/1999
at home drug test, model 9068 PHAMATECH k994233 12/30/1999
at home drug test, model 9073 PHAMATECH k994219 12/30/1999
at home drug test, model 9078 PHAMATECH k994220 12/30/1999
at home drug test, model 9083 PHAMATECH k994234 12/30/1999
at home drug test, model 9133 PHAMATECH k994236 12/30/1999
atlas multi-purpose dsa system CARES BUILT, INC. k010391 03/12/2001
atomlab 400 and atomlab 500 dose calibrators, models 086-330, -331, -332, -335 and -336 BIODEX MEDICAL SYSTEMS, INC. k090296 02/19/2009
atramat pgc25 poly(glycolide-co-epsilon-caprolactone) surgical sutures INTERNACIONAL FARMACEUTICA, S.A. DE C.V. k072863 05/23/2008

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