The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Ldl Cholesterol, Product No's, 124-01, Ch102-01.
| Device ID | K991664 |
| 510k Number | K991664 |
| Device Name: | LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| 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 | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-14 |
| Decision Date | 1999-08-19 |