The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Apolipoprotein A-i (apo A-i).
| Device ID | K901675 |
| 510k Number | K901675 |
| Device Name: | APOLIPOPROTEIN A-I (APO A-I) |
| Classification | Lipoprotein X, Antigen, Antiserum, Control |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | DEL |
| CFR Regulation Number | 866.5590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-10 |
| Decision Date | 1990-04-26 |