The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Auto Hdl Cholesterol Calibrator.
| Device ID | K970933 |
| 510k Number | K970933 |
| Device Name: | AUTO HDL CHOLESTEROL CALIBRATOR |
| Classification | Calibrator, Primary |
| 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 | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-13 |
| Decision Date | 1997-05-23 |