Company ยท US
Ortho Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1980. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JBQ | Antithrombin Iii Quantitation | 2 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 2 |
| JPK | Mixture, Hematology Quality Control | 2 |
| KSF | Kit, Quality Control For Blood Banking Reagents | 2 |
| KSG | Media, Potentiating For In Vitro Diagnostic Use | 2 |
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 |
| DOG | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol | 1 |
| GFO | Activated Partial Thromboplastin | 1 |
| GKH | Apparatus, Automated Blood Cell Diluting | 1 |
| GOK | Antisera, Hai (Including Hai Control), Rubella | 1 |
| GOL | Antigen, Ha (Including Ha Control), Rubella | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| LAS | Drug Specific Control Materials | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 1980 | K802404 | ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE Ortho Diagnostics, Inc. | DCF |
| Aug 20, 1980 | K801507 | ANTIGEN CONTROL CELLS Ortho Diagnostics, Inc. | GOL |
| Apr 16, 1980 | K800357 | BI-LEVEL ASSAYED CARD. DRUG CONT., I,II Ortho Diagnostics, Inc. | LAS |
| Mar 5, 1980 | K800310 | ORTHO ANTISERA CONTROL Ortho Diagnostics, Inc. | KSF |
| Oct 11, 1979 | K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION Ortho Diagnostics, Inc. | KSG |
| Sep 24, 1979 | K791301 | ORTHO TSH RIA KIT Ortho Diagnostics, Inc. | JLW |
| Jun 28, 1979 | K790813 | MULTECON BLOOD GAS CONTROL Ortho Diagnostics, Inc. | JJS |
| Apr 4, 1979 | K782166 | SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 Ortho Diagnostics, Inc. | JHJ |
| Apr 4, 1979 | K782063 | PREGNANCY, SENSIDEX TUBE TEST Ortho Diagnostics, Inc. | JHJ |
| Dec 20, 1978 | K781638 | RUBINDEX*DIRECT SYSTEM Ortho Diagnostics, Inc. | GOK |
| Dec 4, 1978 | K781860 | ASSAY, CHROMOGENIC ANTITHROMBIN III Ortho Diagnostics, Inc. | JBQ |
| Oct 17, 1978 | K781573 | ABNORMAL HEMATOLOGY CONTROL UNASSAYED Ortho Diagnostics, Inc. | JPK |
| Oct 17, 1978 | K781572 | NORMAL HEMATOLOGY CONTROL UNASSAYED Ortho Diagnostics, Inc. | JPK |
| Sep 27, 1978 | K781483 | ORTHO*T-4 RIA (PEG) KIT Ortho Diagnostics, Inc. | CDX |
| Sep 27, 1978 | K781482 | ORTHO*T-3 UPTAKE KIT Ortho Diagnostics, Inc. | KHQ |
| Sep 27, 1978 | K781481 | ORTHO*T-3 RIA (PEG) KIT Ortho Diagnostics, Inc. | CDP |
| Sep 14, 1978 | K781435 | ORTHO LOW IONIC SOLUTION Ortho Diagnostics, Inc. | KSG |
| Aug 31, 1978 | K781335 | DIGOXIN RIA (PEG) KIT Ortho Diagnostics, Inc. | DOG |
| Aug 10, 1978 | K781104 | PLASMA COAGULATION CONT., ABNORMAL Ortho Diagnostics, Inc. | GFO |
| Jan 31, 1978 | K780002 | ANTITHROMBIN III ASSAY Ortho Diagnostics, Inc. | JBQ |
| Nov 8, 1977 | K771488 | P1 BLOOD GROUP SUBSTANCE Ortho Diagnostics, Inc. | KSX |
| Nov 8, 1977 | K771487 | LEWIS BLOOD GROUP SUBSTANCE Ortho Diagnostics, Inc. | KSX |
| Nov 7, 1977 | K771814 | REAGENT CONFIDENCE SERA Ortho Diagnostics, Inc. | KSF |
| Feb 7, 1977 | K761137 | MICROSAMPLE BLOOD COLLECTION DEVICE Ortho Diagnostics, Inc. | GKH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||