Ortho-Clinical Diagnostics - FDA 510(k) Cleared Devices
38
Total
38
Cleared
0
Denied
FDA 510(k) cleared devices by Ortho-Clinical Diagnostics Chemistry ✕
23 devices
Cleared
May 08, 2024
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
Chemistry
183d
Cleared
Sep 05, 2023
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Chemistry
498d
Cleared
Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
Chemistry
158d
Cleared
Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
Chemistry
504d
Cleared
Sep 18, 2017
VITROS Chemistry Products GLU Slides
Chemistry
285d
Cleared
Jul 14, 2017
VITROS Chemistry Products hsCRP Reagent
Chemistry
486d
Cleared
May 16, 2017
VITROS Immunodiagnostic Products Insulin Calibrators
Chemistry
25d
Cleared
Dec 16, 2016
VITROS Chemistry Products Cl- Slides
Chemistry
148d
Cleared
Jun 04, 2015
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31,...
Chemistry
262d
Cleared
Oct 22, 2010
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS...
Chemistry
105d
Cleared
Dec 22, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS...
Chemistry
56d
Cleared
Apr 09, 2007
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS,...
Chemistry
115d
Cleared
Jan 05, 2007
VITROS CHEMISTRY PRODUCTS BARB REAGENT
Chemistry
161d
Cleared
Dec 19, 2006
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE...
Chemistry
89d
Cleared
Jul 03, 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND...
Chemistry
130d
Cleared
Sep 09, 2004
THE VITROS 5,1 FS CHEMISTRY SYSTEM
Chemistry
71d
Cleared
Aug 07, 2003
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK,...
Chemistry
45d
Cleared
Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT...
Chemistry
63d
Cleared
Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
Chemistry
24d
Cleared
Apr 12, 2002
MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/...
Chemistry
42d
Cleared
Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
Chemistry
30d
Cleared
Jun 21, 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
Chemistry
9d
Cleared
Oct 04, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
Chemistry
21d