N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

System, Test, Low Density, Lipoprotein

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for N-geneous Ldl-st Cholesterol Reagent, N-geneous Ldl-st Cholesterol Calibrator, Genzyme Ldl Cholesterol Control Set.

Pre-market Notification Details

• Device ID: K992766
• 510k Number: K992766
• Device Name: N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
• Classification: System, Test, Low Density, Lipoprotein
• Applicant: GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562
• Contact: Barbara Pizza
• Correspondent: Barbara Pizza; GENZYME CORP. 500 KENDALL STREET Cambridge, MA 02142 -1562
• Product Code: MRR
• Subsequent Product Code: JIS
• Subsequent Product Code: JJX
• CFR Regulation Number: 862.1475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-08-17
• Decision Date: 1999-10-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00628063400775	K992766	000
00628063400768	K992766	000
00628063400751	K992766	000
00628063400744	K992766	000
00628063400737	K992766	000
00628063400720	K992766	000