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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 6 of 6 Results
ProductCode: JIT Applicant: BIOKIT S.A. Decision Date To: 04/25/2024
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lp(a) calibrators, and lp(a) controls BIOKIT S.A. K132400 12/19/2013
architect 25-oh vitamin d 100t, vitamin d 500t, vitamin d calibrators, vitamin d controls BIOKIT S.A. K110619 11/23/2011
architect c-peptide calibrators, and architect c-peptide controls, models 3l53-01, 3l53-10 BIOKIT S.A. K082141 09/03/2008
architect intact pth reagents, calibrators (a-f) and controls (low, medium, high), models 8k25-20, 8k25-25, 8k25-01 BIOKIT S.A. K063232 06/19/2007
architect shbg reagent kit, architect shbg calibrator kit, and architect shbg control kit with models, 8k26-25, 8k26-01 BIOKIT S.A. K060818 01/23/2007
architect dhea-s calibrators (a-f) and controls (low, medium and high) BIOKIT S.A. K060027 01/26/2006
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