Ortho Diagnostics, Inc.
Medical device manufacturer in Mchenry, IL.
24510(k) clearances
0PMA approvals
0recalls
Device types
- KSF Kit, Quality Control For Blood Banking… 2
- KSX Substance, Blood Grouping Of Non-Human… 2
- JBQ Antithrombin Iii Quantitation 2
- KSG Media, Potentiating For In Vitro Diagnostic… 2
- JPK Mixture, Hematology Quality Control 2
- JHJ Agglutination Method, Human Chorionic… 2
- DCF Albumin, Antigen, Antiserum, Control 1
- GKH Apparatus, Automated Blood Cell Diluting 1
- GOL Antigen, Ha (Including Ha Control), Rubella 1
- LAS Drug Specific Control Materials 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- JJS Controls For Blood-Gases, (Assayed And… 1
- GOK Antisera, Hai (Including Hai Control)… 1
- CDX Radioimmunoassay, Total Thyroxine 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- DOG Radioimmunoassay, Digoxin (125-I), Rabbit… 1
- GFO Activated Partial Thromboplastin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800357 | Bi-Level Assayed Card. Drug Cont., I,IiLAS · Traditional | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
| K781860 | Assay, Chromogenic Antithrombin IIIJBQ · Traditional | 12/04/1978SE |
| K781573 | Abnormal Hematology Control UnassayedJPK · Traditional | 10/17/1978SE |
| K781572 | Normal Hematology Control UnassayedJPK · Traditional | 10/17/1978SE |
| K781483 | ORTHO*T-4 Ria (Peg) KitCDX · Traditional | 09/27/1978SE |
| K781482 | ORTHO*T-3 Uptake KitKHQ · Traditional | 09/27/1978SE |
| K781481 | ORTHO*T-3 Ria (Peg) KitCDP · Traditional | 09/27/1978SE |
| K781435 | Ortho Low Ionic SolutionKSG · Traditional | 09/14/1978SE |
| K781335 | Digoxin Ria (Peg) KitDOG · Traditional | 08/31/1978SE |
| K781104 | Plasma Coagulation Cont., AbnormalGFO · Traditional | 08/10/1978SE |
| K780002 | Antithrombin III AssayJBQ · Traditional | 01/31/1978SE |
| K771488 | P1 Blood Group SubstanceKSX · Traditional | 11/08/1977SE |
| K771487 | Lewis Blood Group SubstanceKSX · Traditional | 11/08/1977SE |
| K771814 | Reagent Confidence SeraKSF · Traditional | 11/07/1977SE |
| K761137 | Microsample Blood Collection DeviceGKH · Traditional | 02/07/1977SE |