The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Ultra N-geneous Hdl Cholesterol Reagent 1/reagent2; Ultra N-geneous Hdl Cholestreol Calibrator.
| Device ID | K021316 |
| 510k Number | K021316 |
| Device Name: | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | Barabra Pizza |
| Correspondent | Barabra Pizza 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 | 2002-04-25 |
| Decision Date | 2002-07-25 |
| Summary: | summary |