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 |