Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho-Clinical Diagnostics, Inc. — Predicate Candidate Screening
106 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
177 days90th percentile
106clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | Ortho-Clinical Diagnostics, Inc. | 2025-10-29 | 90 | 0 |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reage | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 | 591 | 0 |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent | Ortho-Clinical Diagnostics, Inc. | 2023-05-05 | 592 | 0 |
| K210858 | VITROS Chemistry Products PHBR Slides | Ortho-Clinical Diagnostics, Inc. | 2021-08-13 | 143 | 0 |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-06-07 | 23 | 0 |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-26 | 28 | 2 |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 | 30 | 0 |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-27 | 27 | 0 |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | 2019-03-14 | 29 | 0 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Prod | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 | 90 | 11 |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Produc | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 | 90 | 1 |
| K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | 2016-10-18 | 239 | 0 |
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | 2016-05-20 | 28 | 0 |
| K130332 | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | Ortho-Clinical Diagnostics, Inc. | 2013-05-31 | 109 | 1 |
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, | Ortho-Clinical Diagnostics, Inc. | 2013-05-15 | 146 | 0 |
| K121608 | VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGE | Ortho-Clinical Diagnostics, Inc. | 2013-02-15 | 259 | 1 |
| K120765 | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-10-24 | 225 | 1 |
| K120609 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 | 191 | 1 |
| K093611 | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY P | Ortho-Clinical Diagnostics, Inc. | 2010-04-15 | 143 | 0 |
| K091861 | VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND | Ortho-Clinical Diagnostics, Inc. | 2009-09-03 | 76 | 0 |
| K072732 | ORTHO T. CRUZI ELISA TEST SYSTEM | Ortho-Clinical Diagnostics, Inc. | 2009-04-15 | 567 | 0 |
| K083680 | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2009-02-27 | 77 | 1 |
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBR | Ortho-Clinical Diagnostics, Inc. | 2008-10-23 | 143 | 26 |
| K082099 | VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRO | Ortho-Clinical Diagnostics, Inc. | 2008-08-21 | 27 | 0 |
| K081411 | VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUC | Ortho-Clinical Diagnostics, Inc. | 2008-06-30 | 41 | 2 |
| K073157 | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2007-12-07 | 29 | 0 |
| K072443 | VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT | Ortho-Clinical Diagnostics, Inc. | 2007-09-24 | 25 | 1 |
| K072440 | VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALI | Ortho-Clinical Diagnostics, Inc. | 2007-09-20 | 21 | 3 |
| K071801 | VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL | Ortho-Clinical Diagnostics, Inc. | 2007-07-20 | 18 | 0 |
| K071216 | VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 | 23 | 1 |
| K071215 | VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2007-05-25 | 23 | 0 |
| K063164 | VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS | Ortho-Clinical Diagnostics, Inc. | 2006-12-28 | 71 | 1 |
| K063143 | VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AN | Ortho-Clinical Diagnostics, Inc. | 2006-12-26 | 71 | 0 |
| K062285 | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, F | Ortho-Clinical Diagnostics, Inc. | 2006-12-22 | 137 | 0 |
| K062460 | VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 | 114 | 1 |
| K063591 | VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS | Ortho-Clinical Diagnostics, Inc. | 2006-12-15 | 14 | 1 |
| K062637 | VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, D | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 | 78 | 0 |
| K062094 | VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 | 121 | 0 |
| K062077 | VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; F | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 | 124 | 0 |
| K062123 | VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, F | Ortho-Clinical Diagnostics, Inc. | 2006-11-16 | 114 | 1 |
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMAT | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 | 28 | 24 |
| K060770 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, | Ortho-Clinical Diagnostics, Inc. | 2006-09-15 | 177 | 0 |
| K060678 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK | Ortho-Clinical Diagnostics, Inc. | 2006-09-14 | 184 | 0 |
| K061588 | VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PROD | Ortho-Clinical Diagnostics, Inc. | 2006-07-21 | 43 | 1 |
| K061464 | VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRAT | Ortho-Clinical Diagnostics, Inc. | 2006-06-15 | 21 | 0 |
| K060632 | VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CAL | Ortho-Clinical Diagnostics, Inc. | 2006-06-06 | 89 | 0 |
| K060940 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTR | Ortho-Clinical Diagnostics, Inc. | 2006-04-24 | 18 | 0 |
| K060650 | VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; | Ortho-Clinical Diagnostics, Inc. | 2006-04-06 | 24 | 0 |
| K052867 | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 | 73 | 0 |
| K052819 | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda