The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Iron Reagent.
| Device ID | K891155 |
| 510k Number | K891155 |
| Device Name: | IRON REAGENT |
| Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | CFM |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-04-18 |