The following data is part of a premarket notification filed by J.s. Medical Assoc. with the FDA for J&s Iron Reagents.
| Device ID | K912716 |
| 510k Number | K912716 |
| Device Name: | J&S IRON REAGENTS |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Contact | Marshall E Deutsch |
| Correspondent | Marshall E Deutsch J.S. MEDICAL ASSOC. 19 STRATHMORE RD. Natick, MA 01760 |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1991-09-25 |