Ortho Diagnostics, Inc.
Ortho Diagnostics, Inc. appears in FDA public data with 0 recalls, 24 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 23, 1980.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 24
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K802404 | ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE | October 23, 1980 |
| K801507 | ANTIGEN CONTROL CELLS | August 20, 1980 |
| K800357 | BI-LEVEL ASSAYED CARD. DRUG CONT., I,II | April 16, 1980 |
| K800310 | ORTHO ANTISERA CONTROL | March 5, 1980 |
| K791791 | ORTHO ANTIBODY ENHANCEMENT SOLUTION | October 11, 1979 |
| K791301 | ORTHO TSH RIA KIT | September 24, 1979 |
| K790813 | MULTECON BLOOD GAS CONTROL | June 28, 1979 |
| K782063 | PREGNANCY, SENSIDEX TUBE TEST | April 4, 1979 |
| K782166 | SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 | April 4, 1979 |
| K781638 | RUBINDEX*DIRECT SYSTEM | December 20, 1978 |
| K781860 | ASSAY, CHROMOGENIC ANTITHROMBIN III | December 4, 1978 |
| K781573 | ABNORMAL HEMATOLOGY CONTROL UNASSAYED | October 17, 1978 |
| K781572 | NORMAL HEMATOLOGY CONTROL UNASSAYED | October 17, 1978 |
| K781481 | ORTHO*T-3 RIA (PEG) KIT | September 27, 1978 |
| K781482 | ORTHO*T-3 UPTAKE KIT | September 27, 1978 |
| K781483 | ORTHO*T-4 RIA (PEG) KIT | September 27, 1978 |
| K781435 | ORTHO LOW IONIC SOLUTION | September 14, 1978 |
| K781335 | DIGOXIN RIA (PEG) KIT | August 31, 1978 |
| K781104 | PLASMA COAGULATION CONT., ABNORMAL | August 10, 1978 |
| K780002 | ANTITHROMBIN III ASSAY | January 31, 1978 |