Ortho Diagnostic Systems, Inc.
126 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| KOAGULAB 40-A AUTOMATED COAGULATION SYS (K823131) | Ortho Diagnostic Systems, Inc. | 1982-12-09 |
| ACUSCREEN (K822782) | Ortho Diagnostic Systems, Inc. | 1982-10-08 |
| ORTHO* ALTERNATIVE PATHWAY COMPL. TEST (K821949) | Ortho Diagnostic Systems, Inc. | 1982-08-27 |
| ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX (K821975) | Ortho Diagnostic Systems, Inc. | 1982-08-27 |
| BI-LEVEL ASSAYED TUMOR MARKER & ANTIN (K821026) | Ortho Diagnostic Systems, Inc. | 1982-08-10 |
| ORTHO CLASSICAL PATHWAY COMPL. TEST (K821898) | Ortho Diagnostic Systems, Inc. | 1982-07-16 |
| ORTHO SPECTRUM III & ORTHO-MUNE OK (K820643) | Ortho Diagnostic Systems, Inc. | 1982-07-14 |
| ORTHO CLG IMMUNE COMPLEX TEST SYSTEM (K821806) | Ortho Diagnostic Systems, Inc. | 1982-06-25 |
| FETALSCREEN (K820199) | Ortho Diagnostic Systems, Inc. | 1982-05-12 |
| ORTHO* HEMATOLOGY CONTROL 8 NORMAL (K820400) | Ortho Diagnostic Systems, Inc. | 1982-03-15 |
| ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN (K820392) | Ortho Diagnostic Systems, Inc. | 1982-03-04 |
| BI-LEVEL ASSAYED URINE METAL CONTROL (K820255) | Ortho Diagnostic Systems, Inc. | 1982-02-18 |
| ORTHO CO2 DILUENT LEVEL I (K813293) | Ortho Diagnostic Systems, Inc. | 1981-12-17 |
| ORTHO* UNASSAYED CONTROL SERUM LEVEL I (K813321) | Ortho Diagnostic Systems, Inc. | 1981-12-17 |
| ORTHO CO2 DILUENT LEVEL II (K813294) | Ortho Diagnostic Systems, Inc. | 1981-12-17 |
| ORTHO CO2 DILUENT LEVEL III (K813295) | Ortho Diagnostic Systems, Inc. | 1981-12-17 |
| ORTHO* UNASSAYED CONTROL SERUM LEVEL III (K813322) | Ortho Diagnostic Systems, Inc. | 1981-12-17 |
| ORTHO UNASSAYED CONTROL SERUM LEVEL II (K813167) | Ortho Diagnostic Systems, Inc. | 1981-11-24 |
| ELUAID (K812002) | Ortho Diagnostic Systems, Inc. | 1981-10-28 |
| AVI-D CONTROL (K811713) | Ortho Diagnostic Systems, Inc. | 1981-10-23 |
| ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S (K811567) | Ortho Diagnostic Systems, Inc. | 1981-09-16 |
| ORTHO SICKLE CELL CONTROLS (K811894) | Ortho Diagnostic Systems, Inc. | 1981-07-27 |
| AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM (K811466) | Ortho Diagnostic Systems, Inc. | 1981-06-12 |
| IMIPRAMINE/DISIPRAMINE/LITHIUM (K811465) | Ortho Diagnostic Systems, Inc. | 1981-06-12 |
| DOXEPIN/DESMETHLDOXEPIN/LITHIUM (K811467) | Ortho Diagnostic Systems, Inc. | 1981-06-12 |
| ORTHO QUANTITATIVE FIBRINOGEN ASSAY (K810058) | Ortho Diagnostic Systems, Inc. | 1981-02-26 |
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