The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Crp Latex Immunoturbidimetric Reagent.
| Device ID | K002918 |
| 510k Number | K002918 |
| Device Name: | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT |
| Classification | System, Test, C-reactive Protein |
| Applicant | OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Contact | Michael Campbell |
| Correspondent | Michael Campbell OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. Irving, TX 75063 -3104 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-19 |
| Decision Date | 2000-10-25 |