Medical device manufacturer
Ortho Diagnostic Systems, Inc.
Ortho Diagnostic Systems, Inc. holds 126 FDA 510(k) clearances across 54 product codes. Median elapsed review time is 83 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 126
- Product codes
- 54
- Median review
- 83 days
- Recall records
- 0
How does FDA spell Ortho Diagnostic Systems, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Ortho Diagnostic Systems, Inc. file in?
54 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | 16 | 458 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 13 | 23 days | |
| GJT | Plasma, Coagulation Factor Deficient | 5 | 64 days | |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 64 days | |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 | 61 days | |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 4 | 45 days | |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 4 | 57 days | |
| DAK | Complement C1q, Antigen, Antiserum, Control | 3 | 58 days | |
| GJS | Test, Time, Prothrombin | 3 | 127 days | |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 3 | 100 days | |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 3 | 133 days | |
| MCD | Antigen, Ebv, Capsid | 3 | 63 days | |
| DIF | Drug Mixture Control Materials | 2 | 50 days | |
| GFO | Activated Partial Thromboplastin | 2 | 99 days | |
| GGN | Plasma, Coagulation Control | 2 | 48 days | |
| GKP | Instrument, Coagulation, Automated | 2 | 60 days | |
| HHT | Spatula, Cervical, Cytological | 2 | 42 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 79 days | |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 | 36 days | |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | 34 days | |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 17 days | |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | 94 days | |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 2 | 107 days | |
| LJN | Antibody Igm, If, Epstein-Barr Virus | 2 | 193 days | |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 | 16 days |
Showing the 25 they file in most, of 54.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Ortho Diagnostic Systems, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Ortho Diagnostic Systems, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K951459 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE | GKZ | 837 | |
| K951632 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) | GKZ | 699 | |
| K964754 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE | GKZ | 56 | |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | GIS | 63 | |
| K951100 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) | GKZ | 430 | |
| K950625 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) | GKZ | 458 | |
| K950568 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) | GKZ | 460 | |
| K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) | GKZ | 462 | |
| K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM | GKZ | 891 | |
| K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | GKZ | 211 |
Source: openFDA device/510k · retrieved
Watch what Ortho Diagnostic Systems, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.