The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Abbott Qluickstart Iron Test, Item #5a29.
| Device ID | K913705 |
| 510k Number | K913705 |
| Device Name: | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 |
| Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | CFM |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1991-10-09 |