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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 19 Results
ProductCode: JIX Applicant: ORTHO-CLINICAL DIAGNOSTICS, INC Decision Date To: 08/31/2016
 
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vitros immunodiagnostic products testosterone assay Ortho-Clinical Diagnostics, Inc. K983507 11/04/1998
vitro chemistry products eco2 slide & calibrator kit 2 Ortho-Clinical Diagnostics, Inc. K001133 04/24/2000
vitros chemistry products crea slide, virtros chemistry products calibrator kit 1 Ortho-Clinical Diagnostics, Inc. K001310 05/05/2000
vitros chemistry products alb slide, vitros chemistry products calibrator kit 4 Ortho-Clinical Diagnostics, Inc. K023875 12/10/2002
vitros chemistry products mg slide, vitros chemistry products calibrator kit 1 Ortho-Clinical Diagnostics, Inc. K023876 12/10/2002
vitros chemistry products igg, iga and igm reagents; vitros chemistry product calibrator kit 20; vitros chemistry produc Ortho-Clinical Diagnostics, Inc. K042475 11/10/2004
vitros chemistry products aat reagent, calibrator kit 99 and aat performance verifiers i, ii and iii Ortho-Clinical Diagnostics, Inc. K052819 12/23/2005
vitros chemistry products calibrator kit 99, vitros chemistry products aat/hpt performance verifier i, ii, and iii Ortho-Clinical Diagnostics, Inc. K060940 04/24/2006
vitros chemistry products crea slides,model# 6802584, vitros chemistry products calibrator kit 1,model#1882208 Ortho-Clinical Diagnostics, Inc. K063591 12/15/2006
vitros chemistry products ca dt slides and dt calibrator kit and vitros ca assay Ortho-Clinical Diagnostics, Inc. K072443 09/24/2007
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