Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho Diagnostic Systems, Inc. — Predicate Candidate Screening
126 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
428 days90th percentile
126clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K951459 | ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC | Ortho Diagnostic Systems, Inc. | 1997-07-14 | 837 | 0 |
| K951632 | ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL A | Ortho Diagnostic Systems, Inc. | 1997-03-06 | 699 | 0 |
| K964754 | ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERY | Ortho Diagnostic Systems, Inc. | 1997-01-22 | 56 | 0 |
| K963902 | QUANTITATIVE FIBRINOGEN ASSAY | Ortho Diagnostic Systems, Inc. | 1996-11-29 | 63 | 0 |
| K950568 | ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL | Ortho Diagnostic Systems, Inc. | 1996-05-13 | 460 | 0 |
| K950625 | ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL | Ortho Diagnostic Systems, Inc. | 1996-05-13 | 458 | 0 |
| K951100 | ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONA | Ortho Diagnostic Systems, Inc. | 1996-05-13 | 430 | 0 |
| K950482 | ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL | Ortho Diagnostic Systems, Inc. | 1996-05-10 | 462 | 0 |
| K935720 | ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER | Ortho Diagnostic Systems, Inc. | 1996-05-09 | 891 | 0 |
| K954570 | ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM | Ortho Diagnostic Systems, Inc. | 1996-04-30 | 211 | 0 |
| K955638 | SYNTHAFAX APTT REAGENT | Ortho Diagnostic Systems, Inc. | 1996-04-23 | 134 | 1 |
| K953981 | SYNTHASIL APTT REAGENT | Ortho Diagnostic Systems, Inc. | 1995-11-30 | 99 | 0 |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1995-05-16 | 428 | 0 |
| K940209 | ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL | Ortho Diagnostic Systems, Inc. | 1995-05-11 | 482 | 0 |
| K935748 | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT | Ortho Diagnostic Systems, Inc. | 1995-04-26 | 511 | 0 |
| K932532 | ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) | Ortho Diagnostic Systems, Inc. | 1995-04-26 | 708 | 0 |
| K932531 | ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE | Ortho Diagnostic Systems, Inc. | 1995-04-26 | 708 | 0 |
| K932530 | ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) | Ortho Diagnostic Systems, Inc. | 1995-04-26 | 708 | 0 |
| K941713 | ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) | Ortho Diagnostic Systems, Inc. | 1995-04-26 | 419 | 0 |
| K931443 | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS | Ortho Diagnostic Systems, Inc. | 1993-11-05 | 228 | 0 |
| K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 | 193 | 0 |
| K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 | 193 | 0 |
| K925604 | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT | Ortho Diagnostic Systems, Inc. | 1993-03-12 | 127 | 1 |
| K925208 | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | Ortho Diagnostic Systems, Inc. | 1992-12-28 | 91 | 0 |
| K914188 | KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM | Ortho Diagnostic Systems, Inc. | 1992-08-26 | 343 | 0 |
| K921321 | ORTHO CHLAMYDIA ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | 1992-08-11 | 148 | 0 |
| K920412 | MODIFIED ORTHO EBV VCA-IGG ELISA | Ortho Diagnostic Systems, Inc. | 1992-06-22 | 143 | 0 |
| K915551 | ORTHO HSV ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | 1992-04-22 | 133 | 0 |
| K911570 | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1991-06-10 | 63 | 0 |
| K911571 | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1991-06-10 | 63 | 0 |
| K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1991-06-10 | 63 | 0 |
| K904253 | ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY | Ortho Diagnostic Systems, Inc. | 1991-05-20 | 248 | 0 |
| K910668 | ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION | Ortho Diagnostic Systems, Inc. | 1991-03-19 | 34 | 0 |
| K903132 | ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF | Ortho Diagnostic Systems, Inc. | 1990-12-21 | 157 | 0 |
| K905077 | ORTHO CMV-M ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1990-12-17 | 34 | 0 |
| K905078 | ORTHO CMV-G ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1990-12-17 | 34 | 0 |
| K905079 | ORTHO RUBELLA-M ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1990-12-04 | 21 | 0 |
| K902210 | ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA | Ortho Diagnostic Systems, Inc. | 1990-07-03 | 48 | 0 |
| K901327 | ORTHO CORRECTION REAGENTS | Ortho Diagnostic Systems, Inc. | 1990-05-25 | 65 | 0 |
| K901120 | KOAGULAB 60-S COAGULATION SYSTEM | Ortho Diagnostic Systems, Inc. | 1990-05-22 | 71 | 0 |
| K901233 | ORTHO ABNORMAL PROTEIN C CONTROL PLASMA | Ortho Diagnostic Systems, Inc. | 1990-04-11 | 28 | 0 |
| K900395 | ORTHOKROME* FACTOR VIII | Ortho Diagnostic Systems, Inc. | 1990-03-15 | 45 | 0 |
| K900396 | ORTHOKROME* HEPARIN | Ortho Diagnostic Systems, Inc. | 1990-03-15 | 45 | 0 |
| K900400 | ORTHOKROME* ANTITHROMBIN | Ortho Diagnostic Systems, Inc. | 1990-03-15 | 45 | 0 |
| K900397 | ORTHOKROME* ANTIPLASMIN | Ortho Diagnostic Systems, Inc. | 1990-03-15 | 45 | 0 |
| K900398 | ORTHOKROME* PROTEIN C | Ortho Diagnostic Systems, Inc. | 1990-03-15 | 45 | 0 |
| K900399 | ORTHOKROME* PLASMINOGEN | Ortho Diagnostic Systems, Inc. | 1990-03-15 | 45 | 0 |
| K896479 | ORTHO* RUBELLA-G ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1989-12-29 | 46 | 0 |
| K894420 | ORTHO RESULT PLUS/PREGNANCY | Ortho Diagnostic Systems, Inc. | 1989-10-04 | 79 | 0 |
| K891382 | ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES | Ortho Diagnostic Systems, Inc. | 1989-06-06 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda