The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Direct Tibc Calibrator.
| Device ID | K000783 |
| 510k Number | K000783 |
| Device Name: | DIRECT TIBC CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | REFERENCE DIAGNOSTICS, INC. 23 CROSBY DR. Bedford, MA 01730 |
| Contact | Joseph Lawlor |
| Correspondent | Joseph Lawlor REFERENCE DIAGNOSTICS, INC. 23 CROSBY DR. 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 | 2000-03-10 |
| Decision Date | 2000-05-04 |