The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for N-geneous Ldl Cholesterol Reagent, N-geneous Ldl Cholesterol Calibrator, Genzyme Ldl Cholesterol Control Set.
Device ID | K971573 |
510k Number | K971573 |
Device Name: | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET |
Classification | Ldl & Vldl Precipitation, 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 | LBR |
Subsequent Product Code | JIS |
Subsequent Product Code | JIX |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-30 |
Decision Date | 1997-06-18 |
Summary: | summary |