The following data is part of a premarket notification filed by Clinical Data with the FDA for Atac Iron Reagent, Atac Tibc Column Kit And Iron Calibrator (500 Ug/dl).
| Device ID | K030528 |
| 510k Number | K030528 |
| Device Name: | ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | CLINICAL DATA 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Wynn Stocking CLINICAL DATA 1075 W. LAMBERT RD., SUITE D Brea, CA 92821 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-06-17 |
| Summary: | summary |