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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: JJY Applicant: RANDOX LABORATORIES LIMITED Decision Date To: 10/26/2020
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liquid assayed chemistry control premium plus level 1,2 and level 3. RANDOX LABORATORIES LIMITED K140971 12/08/2014
randox immunoassay premium plus control levels 1,2 and level 3 and immunoassay premium plus tri-level control RANDOX LABORATORIES LIMITED K140522 05/22/2014
randox ammonia ethanol control levels 1, 2 and level 3 RANDOX LABORATORIES LIMITED K140393 03/25/2014
randox speciality control (i) levels 1, 2 and 3 RANDOX LABORATORIES LIMITED K130337 06/19/2013
randox liquid cardiac control levels 1, 2 and 3 RANDOX LABORATORIES LIMITED K110534 01/23/2012
randox tri level cardiac control RANDOX LABORATORIES LIMITED K041361 09/09/2004
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