Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US
Ortho Diagnostic Systems, Inc. appears in FDA device records in Carpinteria, CA. FDA records list 126 510(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
- 126
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 126FDA records hold 126 510(k) clearances for Ortho Diagnostic Systems, Inc. between 1981 and 1997. The busiest year on record is 1981, with 14. The most recent is 1997, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 14 |
| 1982 | 12 |
| 1983 | 8 |
| 1984 | 12 |
| 1985 | 7 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 12 |
| 1989 | 8 |
| 1990 | 14 |
| 1991 | 5 |
| 1992 | 5 |
| 1993 | 4 |
| 1995 | 8 |
| 1996 | 8 |
| 1997 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K951459 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE | GKZ | Substantially Equivalent | |
| K951632 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K964754 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE | GKZ | Substantially Equivalent | |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | GIS | Substantially Equivalent | |
| K951100 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K950625 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K950568 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM | GKZ | Substantially Equivalent | |
| K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | GKZ | Substantially Equivalent | |
| K955638 | SYNTHAFAX APTT REAGENT | GFO | Substantially Equivalent | |
| K953981 | SYNTHASIL APTT REAGENT | GFO | Substantially Equivalent | |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | CKD | Substantially Equivalent | |
| K940209 | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL | GGN | Substantially Equivalent | |
| K941713 | ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K935748 | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT | GJS | Substantially Equivalent | |
| K932532 | ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K932531 | ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE | GKZ | Substantially Equivalent | |
| K932530 | ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) | GKZ | Substantially Equivalent | |
| K931443 | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS | LSE | Substantially Equivalent | |
| K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | LJN | Substantially Equivalent | |
| K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | LLM | Substantially Equivalent | |
| K925604 | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT | GJS | Substantially Equivalent | |
| K925208 | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | LGC | Substantially Equivalent | |
| K914188 | KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM | JPA | Substantially Equivalent | |
| K921321 | ORTHO CHLAMYDIA ANTIGEN ELISA TEST | LJC | Substantially Equivalent | |
| K920412 | MODIFIED ORTHO EBV VCA-IGG ELISA | MCD | Substantially Equivalent | |
| K915551 | ORTHO HSV ANTIGEN ELISA TEST | LGC | Substantially Equivalent | |
| K911571 | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST | MCD | Substantially Equivalent | |
| K911570 | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST | MCD | Substantially Equivalent | |
| K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | LLM | Substantially Equivalent | |
| K904253 | ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY | GKZ | Substantially Equivalent | |
| K910668 | ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION | LJC | Substantially Equivalent | |
| K903132 | ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF | LJC | Substantially Equivalent | |
| K905078 | ORTHO CMV-G ANTIBODY ELISA TEST | LFZ | Substantially Equivalent | |
| K905077 | ORTHO CMV-M ANTIBODY ELISA TEST | LFZ | Substantially Equivalent | |
| K905079 | ORTHO RUBELLA-M ANTIBODY ELISA TEST | LFX | Substantially Equivalent | |
| K902210 | ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA | GGN | Substantially Equivalent | |
| K901327 | ORTHO CORRECTION REAGENTS | GJT | Substantially Equivalent | |
| K901120 | KOAGULAB 60-S COAGULATION SYSTEM | GKP | Substantially Equivalent | |
| K901233 | ORTHO ABNORMAL PROTEIN C CONTROL PLASMA | GGC | Substantially Equivalent | |
| K900400 | ORTHOKROME* ANTITHROMBIN | JBQ | Substantially Equivalent | |
| K900399 | ORTHOKROME* PLASMINOGEN | GGP | Substantially Equivalent | |
| K900398 | ORTHOKROME* PROTEIN C | GGP | Substantially Equivalent | |
| K900397 | ORTHOKROME* ANTIPLASMIN | GGP | Substantially Equivalent | |
| K900396 | ORTHOKROME* HEPARIN | KFF | Substantially Equivalent | |
| K900395 | ORTHOKROME* FACTOR VIII | GGP | Substantially Equivalent | |
| K896479 | ORTHO* RUBELLA-G ANTIBODY ELISA TEST | LFX | Substantially Equivalent | |
| K894420 | ORTHO RESULT PLUS/PREGNANCY | JHI | Substantially Equivalent | |
| K891382 | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES | GQL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GKAAbnormal Hemoglobin Quantitation
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- GFOActivated Partial Thromboplastin
- JHJAgglutination Method, Human Chorionic Gonadotropin
- LJNAntibody Igm, If, Epstein-Barr Virus
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GQNAntigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
- MCDAntigen, Ebv, Capsid
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- GQXAntiserum, Cf, Varicella-Zoster
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- JBQAntithrombin Iii Quantitation
- MSJApolipoproteins
- LCPAssay, Glycosylated Hemoglobin
- KFFAssay, Heparin
- LIZAssay, T Lymphocyte Surface Marker
- KIRCells, Animal And Human, Cultured
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- DAKComplement C1q, Antigen, Antiserum, Control
- GGCControl, Plasma, Abnormal
- GKZCounter, Differential Cell
- JSMCulture Media, Non-Propagating Transport
- LSLDna-Reagents, Neisseria
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
- LSEEpstein-Barr Virus, Other
- CKDHydrazone Colorimetry, Alt/Sgpt
- KQGInstrument, Coagulation
- GKPInstrument, Coagulation, Automated
- KSFKit, Quality Control For Blood Banking Reagents
- JXAKit, Screening, Urine
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GGKProducts, Red-Cell Lysing Products
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- HHTSpatula, Cervical, Cytological
- KQJSystem, Fibrinogen Determination
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
- GISTest, Fibrinogen
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
- JHIVisual, Pregnancy Hcg, Prescription 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