The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Hba1c Reagent, (catalog Number Osr6192), Olympus Hba1c Calibrator, (catolog Number Odc3032).
| Device ID | K031380 |
| 510k Number | K031380 |
| Device Name: | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-01 |
| Decision Date | 2003-11-14 |