The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Modification To Lipoprotein (a) Spq Iii Antibody Reagent Set.
| Device ID | K001118 |
| 510k Number | K001118 |
| Device Name: | MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | DIASORIN, INC. 4029 CHARIOT'S FLIGHT WAY Ellicott City, MD 21042 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith DIASORIN, INC. 4029 CHARIOT'S FLIGHT WAY Ellicott City, MD 21042 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-07 |
| Decision Date | 2000-04-25 |