The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for N-geneous Hdl Cholesterol Kit/cholesterol Calibrator.
| Device ID | K971190 |
| 510k Number | K971190 |
| Device Name: | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | Nancy E Isaac |
| Correspondent | Nancy E Isaac GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-06-16 |
| Summary: | summary |