The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Autohdl Cholesterol Reagent Set.
| Device ID | K992002 |
| 510k Number | K992002 |
| Device Name: | AUTOHDL CHOLESTEROL REAGENT SET |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-15 |
| Decision Date | 1999-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015051 | K992002 | 000 |
| 00811727016171 | K992002 | 000 |
| 00817439020864 | K992002 | 000 |
| 00817439020871 | K992002 | 000 |
| 00817439020888 | K992002 | 000 |
| 00817439021151 | K992002 | 000 |
| 00811727011374 | K992002 | 000 |
| 00811727011381 | K992002 | 000 |
| 00811727011398 | K992002 | 000 |
| 00811727011404 | K992002 | 000 |
| 00811727012807 | K992002 | 000 |
| 00811727012913 | K992002 | 000 |
| 00811727013552 | K992002 | 000 |
| 00811727015860 | K992002 | 000 |