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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 3 of 3 Results
ProductCode: DLJ Applicant: BIOKIT S.A. Decision Date To: 06/07/2024
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architect idigoxin and architect idigoxin calibrators, models 1p32-25 and ip32-01 BIOKIT S.A. K082953 12/22/2008
architect ivancomycin reagents and architect ivancomycin calibrators, models: 1p30-25 and 1p30-01 BIOKIT S.A. K072036 03/19/2008
architect i theophylline reagents and calibrators (a-f) BIOKIT S.A. K070810 06/08/2007
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