The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Iron.
| Device ID | K972363 |
| 510k Number | K972363 |
| Device Name: | IL TEST IRON |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Betty J Lane |
| Correspondent | Betty J Lane INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-25 |
| Decision Date | 1997-08-15 |
| Summary: | summary |