Ortho-Clinical Diagnostics, Inc. · Class II · Cleared Oct 22, 1997
| K-number | K973331 |
| Device name | VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) |
| Applicant | Ortho-Clinical Diagnostics, Inc. |
| Product code | DBF |
| Device class | Class II |
| Decision date | Oct 22, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 866.5340 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov