The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Vitalab Iron Reagent.
| Device ID | K033983 |
| 510k Number | K033983 |
| Device Name: | VITALAB IRON REAGENT |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | CLINICAL DATA, INC. 1075 W. LAMBERT ROAD SUITE D Brea, CA 92821 |
| Contact | Wynn Stocking |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-12-23 |
| Decision Date | 2004-05-21 |
| Summary: | summary |