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Ortho Clinical Diagnostics

38 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
VITROS Immunodiagnostic Products Syphilis Reagent Pack (K241534)Ortho Clinical Diagnostics2024-08-28
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581)Ortho Clinical Diagnostics2024-05-08
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (K221197)Ortho Clinical Diagnostics2023-09-05
VITROS Immunodiagnostic Products CEA Reagent Pack (K231517)Ortho Clinical Diagnostics2023-08-23
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525)Ortho Clinical Diagnostics2023-08-09
VITROS Immuodiagnostic Products CA 125 II Reagent Pack (K221355)Ortho Clinical Diagnostics2022-12-12
VITROS AFP (K213626)Ortho Clinical Diagnostics2022-06-15
VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648)Ortho Clinical Diagnostics2022-01-28
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (K201312)Ortho Clinical Diagnostics2021-10-04
VITROS BRAHMS PCT Reagent Pack and Calibrators (K200236)Ortho Clinical Diagnostics2020-02-25
VITROS Chemistry Products GLU Slides (K163433)Ortho Clinical Diagnostics2017-09-18
VITROS Chemistry Products hsCRP Reagent (K160712)Ortho Clinical Diagnostics2017-07-14
VITROS Immunodiagnostic Products Insulin Calibrators (K171168)Ortho Clinical Diagnostics2017-05-16
VITROS Chemistry Products Cl- Slides (K162020)Ortho Clinical Diagnostics2016-12-16
VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433)Ortho Clinical Diagnostics2015-09-24
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II (K142595)Ortho Clinical Diagnostics2015-06-04
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT (K101921)Ortho-Clinical Diagnostics2010-10-22
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (K083173)Ortho-Clinical Diagnostics2008-12-22
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS (K063720)Ortho-Clinical Diagnostics2007-04-09
VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062165)Ortho-Clinical Diagnostics2007-01-05
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 (K062838)Ortho-Clinical Diagnostics2006-12-19
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS (K060480)Ortho-Clinical Diagnostics2006-07-03
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; (K052645)Ortho-Clinical Diagnostics2005-12-14
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III (K042494)Ortho-Clinical Diagnostics2004-10-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K042303)Ortho-Clinical Diagnostics2004-09-27
THE VITROS 5,1 FS CHEMISTRY SYSTEM (K041764)Ortho-Clinical Diagnostics2004-09-09
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS (K033127)Ortho-Clinical Diagnostics2003-10-31
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 (K031924)Ortho-Clinical Diagnostics2003-08-07
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS (K024193)Ortho-Clinical Diagnostics2003-02-21
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K030067)Ortho-Clinical Diagnostics2003-01-17
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS (K022901)Ortho-Clinical Diagnostics2002-09-27
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS (K020662)Ortho-Clinical Diagnostics2002-04-12
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS (K013899)Ortho-Clinical Diagnostics2002-01-24
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS (K013900)Ortho-Clinical Diagnostics2001-12-21
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS (K012561)Ortho-Clinical Diagnostics2001-08-29
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS (K011463)Ortho-Clinical Diagnostics2001-06-13
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT (K001769)Ortho-Clinical Diagnostics2000-06-21
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS (K993068)Ortho-Clinical Diagnostics1999-10-04

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Every clearance here is in the API, with alerts when new ones post.