The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Photometric Method, Iron (non-heme) (75jiy).
| Device ID | K890034 |
| 510k Number | K890034 |
| Device Name: | PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY) |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-04 |
| Decision Date | 1989-02-03 |