The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Ferritin Calibrator Set, Catalog No. 8203.
| Device ID | K053291 |
| 510k Number | K053291 |
| Device Name: | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 |
| Classification | Calibrator, Secondary |
| Applicant | REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford, MA 01730 |
| Contact | Joseph Lawlor |
| Correspondent | Joseph Lawlor REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 Bedford, MA 01730 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-25 |
| Decision Date | 2006-03-13 |