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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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px 53/15-bp, model 130 050 and px 60/15-bp, model 130 051 BIOTRONIK, GMBH & CO. k000763 04/06/2000
quanta lite asca (s. cerevisiae) igg elisa INOVA DIAGNOSTICS, INC. den000007 08/16/2000
quanta lite lkm-1 elisa INOVA DIAGNOSTICS, INC. k000535 06/07/2000
quantase phenylalanine screening assay 500 test kit QUANTASE LTD. k000754 06/19/2000
quickair choke reliever, model 59-001a MAET INDUSTRIES, INC. den000004 02/29/2000
r-si-line metal-bite R-DENTAL DENTALERZEUGNISSE GMBH k010926 04/12/2001
reaads igg anti-prothrombin semi-quantitative test kit CORGENIX, INC. k001352 04/09/2001
reach femoral component BIOMET, INC. k000760 05/23/2000
rebar micro catheter: rebar-18 [2.3f], 110 cm, 130 cm, 153 cm, single marker band and 153 cm, dual marker band MICRO THERAPEUTICS, INC. k001966 07/20/2000
resin cem S & C POLYMER GMBH k011431 06/11/2001

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