The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Autoldl Cholesterol Reagent Set And Autoldl Cholesterol Calibrator.
| Device ID | K981978 |
| 510k Number | K981978 |
| Device Name: | AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters, Jr. |
| Correspondent | William F Walters, Jr. POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-05 |
| Decision Date | 1998-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015082 | K981978 | 000 |
| 00811727016218 | K981978 | 000 |
| 00817439021014 | K981978 | 000 |
| 00817439021021 | K981978 | 000 |
| 00811727011763 | K981978 | 000 |
| 00811727011770 | K981978 | 000 |
| 00811727011787 | K981978 | 000 |
| 00811727013071 | K981978 | 000 |
| 00811727013637 | K981978 | 000 |
| 00811727015914 | K981978 | 000 |