The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Apolipoprotien A-1 (apo A-1).
| Device ID | K932606 |
| 510k Number | K932606 |
| Device Name: | APOLIPOPROTIEN A-1 (APO A-1) |
| Classification | Turbidimetric Method, Lipoproteins |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | JHN |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-28 |
| Decision Date | 1994-06-02 |