Ortho Diagnostics, Inc.
Mchenry, IL, US
Ortho Diagnostics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Ortho Diagnostics, Inc. between 1977 and 1980. The busiest year on record is 1978, with 11. The most recent is 1980, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 4 |
| 1978 | 11 |
| 1979 | 5 |
| 1980 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K802404 | ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE | DCF | Substantially Equivalent | |
| K801507 | ANTIGEN CONTROL CELLS | GOL | Substantially Equivalent | |
| K800357 | BI-LEVEL ASSAYED CARD. DRUG CONT., I,II | LAS | Substantially Equivalent | |
| K800310 | ORTHO ANTISERA CONTROL | KSF | Substantially Equivalent | |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | KSG | Substantially Equivalent | |
| K791301 | ORTHO TSH RIA KIT | JLW | Substantially Equivalent | |
| K790813 | MULTECON BLOOD GAS CONTROL | JJS | Substantially Equivalent | |
| K782166 | SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 | JHJ | Substantially Equivalent | |
| K782063 | PREGNANCY, SENSIDEX TUBE TEST | JHJ | Substantially Equivalent | |
| K781638 | RUBINDEX*DIRECT SYSTEM | GOK | Substantially Equivalent | |
| K781860 | ASSAY, CHROMOGENIC ANTITHROMBIN III | JBQ | Substantially Equivalent | |
| K781573 | ABNORMAL HEMATOLOGY CONTROL UNASSAYED | JPK | Substantially Equivalent | |
| K781572 | NORMAL HEMATOLOGY CONTROL UNASSAYED | JPK | Substantially Equivalent | |
| K781483 | ORTHO*T-4 RIA (PEG) KIT | CDX | Substantially Equivalent | |
| K781482 | ORTHO*T-3 UPTAKE KIT | KHQ | Substantially Equivalent | |
| K781481 | ORTHO*T-3 RIA (PEG) KIT | CDP | Substantially Equivalent | |
| K781435 | ORTHO LOW IONIC SOLUTION | KSG | Substantially Equivalent | |
| K781335 | DIGOXIN RIA (PEG) KIT | DOG | Substantially Equivalent | |
| K781104 | PLASMA COAGULATION CONT., ABNORMAL | GFO | Substantially Equivalent | |
| K780002 | ANTITHROMBIN III ASSAY | JBQ | Substantially Equivalent | |
| K771488 | P1 BLOOD GROUP SUBSTANCE | KSX | Substantially Equivalent | |
| K771487 | LEWIS BLOOD GROUP SUBSTANCE | KSX | Substantially Equivalent | |
| K771814 | REAGENT CONFIDENCE SERA | KSF | Substantially Equivalent | |
| K761137 | MICROSAMPLE BLOOD COLLECTION DEVICE | GKH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GFOActivated Partial Thromboplastin
- JHJAgglutination Method, Human Chorionic Gonadotropin
- DCFAlbumin, Antigen, Antiserum, Control
- GOLAntigen, Ha (Including Ha Control), Rubella
- GOKAntisera, Hai (Including Hai Control), Rubella
- JBQAntithrombin Iii Quantitation
- GKHApparatus, Automated Blood Cell Diluting
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- LASDrug Specific Control Materials
- KSFKit, Quality Control For Blood Banking Reagents
- KSGMedia, Potentiating For In Vitro Diagnostic Use
- JPKMixture, Hematology Quality Control
- KHQRadioassay, Triiodothyronine Uptake
- DOGRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- KSXSubstance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain