The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Tibc, Product No's 123-0, 123-02, Fe109-01, Fe109-02.
| Device ID | K991666 |
| 510k Number | K991666 |
| Device Name: | TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 |
| 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 | 1999-05-14 |
| Decision Date | 1999-06-30 |