The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Fructosamine, Model Fr 106-01.
| Device ID | K991246 |
| 510k Number | K991246 |
| Device Name: | FRUCTOSAMINE, MODEL FR 106-01 |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-12-16 |