The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Apolipoprotein A1 And Apolipoprotein B Reagents And Calibrators.
| Device ID | K061377 |
| 510k Number | K061377 |
| Device Name: | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS |
| Classification | Apolipoproteins |
| Applicant | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Contact | William Walters |
| Correspondent | William Walters POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE Canton, MI 48188 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-17 |
| Decision Date | 2007-03-28 |