The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Direct Ldl Cholesterol Immunoseparation Reagent Kit.
| Device ID | K943150 |
| 510k Number | K943150 |
| Device Name: | DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | Alodia M Ruiz |
| Correspondent | Alodia M Ruiz GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-30 |
| Decision Date | 1995-03-15 |