Company ยท US
Ortho Diagnostic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1997. Name variants (Inc, Corp, punctuation) are merged.
126510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 16 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 13 |
| GJT | Plasma, Coagulation Factor Deficient | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 5 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 4 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 4 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 3 |
| GJS | Test, Time, Prothrombin | 3 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 3 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 3 |
| MCD | Antigen, Ebv, Capsid | 3 |
| DIF | Drug Mixture Control Materials | 2 |
| GFO | Activated Partial Thromboplastin | 2 |
| GGN | Plasma, Coagulation Control | 2 |
| GKP | Instrument, Coagulation, Automated | 2 |
| HHT | Spatula, Cervical, Cytological | 2 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 14, 1997 | K951459 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE Ortho Diagnostic Systems, Inc. | GKZ |
| Mar 6, 1997 | K951632 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| Jan 22, 1997 | K964754 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE Ortho Diagnostic Systems, Inc. | GKZ |
| Nov 29, 1996 | K963902 | QUANTITATIVE FIBRINOGEN ASSAY Ortho Diagnostic Systems, Inc. | GIS |
| May 13, 1996 | K951100 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| May 13, 1996 | K950625 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| May 13, 1996 | K950568 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| May 10, 1996 | K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| May 9, 1996 | K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 30, 1996 | K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 23, 1996 | K955638 | SYNTHAFAX APTT REAGENT Ortho Diagnostic Systems, Inc. | GFO |
| Nov 30, 1995 | K953981 | SYNTHASIL APTT REAGENT Ortho Diagnostic Systems, Inc. | GFO |
| May 16, 1995 | K941192 | ORTHO ALT MICROWELL TEST SYSTEM Ortho Diagnostic Systems, Inc. | CKD |
| May 11, 1995 | K940209 | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL Ortho Diagnostic Systems, Inc. | GGN |
| Apr 26, 1995 | K941713 | ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 26, 1995 | K935748 | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT Ortho Diagnostic Systems, Inc. | GJS |
| Apr 26, 1995 | K932532 | ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 26, 1995 | K932531 | ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE Ortho Diagnostic Systems, Inc. | GKZ |
| Apr 26, 1995 | K932530 | ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) Ortho Diagnostic Systems, Inc. | GKZ |
| Nov 5, 1993 | K931443 | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS Ortho Diagnostic Systems, Inc. | LSE |
| Jul 16, 1993 | K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA Ortho Diagnostic Systems, Inc. | LJN |
| Jul 16, 1993 | K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA Ortho Diagnostic Systems, Inc. | LLM |
| Mar 12, 1993 | K925604 | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT Ortho Diagnostic Systems, Inc. | GJS |
| Dec 28, 1992 | K925208 | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION Ortho Diagnostic Systems, Inc. | LGC |
| Aug 26, 1992 | K914188 | KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM Ortho Diagnostic Systems, Inc. | JPA |
| Aug 11, 1992 | K921321 | ORTHO CHLAMYDIA ANTIGEN ELISA TEST Ortho Diagnostic Systems, Inc. | LJC |
| Jun 22, 1992 | K920412 | MODIFIED ORTHO EBV VCA-IGG ELISA Ortho Diagnostic Systems, Inc. | MCD |
| Apr 22, 1992 | K915551 | ORTHO HSV ANTIGEN ELISA TEST Ortho Diagnostic Systems, Inc. | LGC |
| Jun 10, 1991 | K911571 | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | MCD |
| Jun 10, 1991 | K911570 | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | MCD |
| Jun 10, 1991 | K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LLM |
| May 20, 1991 | K904253 | ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY Ortho Diagnostic Systems, Inc. | GKZ |
| Mar 19, 1991 | K910668 | ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION Ortho Diagnostic Systems, Inc. | LJC |
| Dec 21, 1990 | K903132 | ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF Ortho Diagnostic Systems, Inc. | LJC |
| Dec 17, 1990 | K905078 | ORTHO CMV-G ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LFZ |
| Dec 17, 1990 | K905077 | ORTHO CMV-M ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LFZ |
| Dec 4, 1990 | K905079 | ORTHO RUBELLA-M ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LFX |
| Jul 3, 1990 | K902210 | ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA Ortho Diagnostic Systems, Inc. | GGN |
| May 25, 1990 | K901327 | ORTHO CORRECTION REAGENTS Ortho Diagnostic Systems, Inc. | GJT |
| May 22, 1990 | K901120 | KOAGULAB 60-S COAGULATION SYSTEM Ortho Diagnostic Systems, Inc. | GKP |
| Apr 11, 1990 | K901233 | ORTHO ABNORMAL PROTEIN C CONTROL PLASMA Ortho Diagnostic Systems, Inc. | GGC |
| Mar 15, 1990 | K900400 | ORTHOKROME* ANTITHROMBIN Ortho Diagnostic Systems, Inc. | JBQ |
| Mar 15, 1990 | K900399 | ORTHOKROME* PLASMINOGEN Ortho Diagnostic Systems, Inc. | GGP |
| Mar 15, 1990 | K900398 | ORTHOKROME* PROTEIN C Ortho Diagnostic Systems, Inc. | GGP |
| Mar 15, 1990 | K900397 | ORTHOKROME* ANTIPLASMIN Ortho Diagnostic Systems, Inc. | GGP |
| Mar 15, 1990 | K900396 | ORTHOKROME* HEPARIN Ortho Diagnostic Systems, Inc. | KFF |
| Mar 15, 1990 | K900395 | ORTHOKROME* FACTOR VIII Ortho Diagnostic Systems, Inc. | GGP |
| Dec 29, 1989 | K896479 | ORTHO* RUBELLA-G ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | LFX |
| Oct 4, 1989 | K894420 | ORTHO RESULT PLUS/PREGNANCY Ortho Diagnostic Systems, Inc. | JHI |
| Jun 6, 1989 | K891382 | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES Ortho Diagnostic Systems, Inc. | GQL |
Newest 50 of 126.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||