The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Total Iron, Models Fe 109-01, Fe 109-02.
| Device ID | K991244 |
| 510k Number | K991244 |
| Device Name: | TOTAL IRON, MODELS FE 109-01, FE 109-02 |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-05-25 |