The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Direct Tibc Kit.
| Device ID | K000781 |
| 510k Number | K000781 |
| Device Name: | DIRECT TIBC KIT |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| 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 | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-10 |
| Decision Date | 2000-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727013057 | K000781 | 000 |
| 00811727012715 | K000781 | 000 |
| 00811727011640 | K000781 | 000 |
| 00817439021267 | K000781 | 000 |
| 00630414595535 | K000781 | 000 |
| 00630414474748 | K000781 | 000 |
| 00811727016263 | K000781 | 000 |
| 00811727015969 | K000781 | 000 |