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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 7 of 7 Results
ProductCode: JJX Applicant: RANDOX LABORATORIES, LTD. Decision Date To: 05/19/2024
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hba1c control, level 1 and level 2 RANDOX LABORATORIES, LTD. K131999 07/26/2013
aldolase controls level 2, and aldolase control level 3 RANDOX LABORATORIES, LTD. K131776 07/18/2013
randox microalbumin control level 1 and control level 2 (liquid) RANDOX LABORATORIES, LTD. K121746 07/11/2012
randox cystatin c control level 2 randox cystatin c control level 3 RANDOX LABORATORIES, LTD. K121588 06/20/2012
cannabinoid assay and the randox cannabinoid calibrator/ control set RANDOX LABORATORIES, LTD. K092269 04/08/2011
randox liquid crp controls RANDOX LABORATORIES, LTD. K040351 03/12/2004
randox fructosamine, fructosamine calibrator, fructosamine controls RANDOX LABORATORIES, LTD. K023763 01/13/2003
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