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510(k) K992766

N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET by Genzyme Corp. — Product Code MRR

K992766 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET". The FDA issued a decision of Substantially Equivalent on October 18, 1999. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Genzyme Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1999
Date Received
August 17, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Genzyme Corp.

  • K061508 — OSOM INFLUENZA A&B TEST (June 12, 2006)
  • K051244 — GENZYME OSOM INFLUENZA A & B TEST (February 21, 2006)
  • K040241 — N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET (June 25, 2004)
  • K040868 — SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (June 4, 2004)
  • K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST (April 2, 2004)
  • K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST (January 16, 2003)
  • K021316 — ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTR (July 25, 2002)
  • K021019 — COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (June 18, 2002)
  • K012532 — SEPRAGEL SINUS (October 30, 2001)
  • K011843 — GENZYME DIRECT-AMYLASE TEST REAGENT (August 10, 2001)

Other clearances for product code MRR

  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K210801 — AXINON® LDL-p Test System (July 19, 2023)
  • K161691 — Direct LDL Cholesterol (LDL) (March 20, 2017)
  • K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (August 3, 2009)
  • K090734 — EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROL (July 17, 2009)
  • K063841 — NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (July 23, 2008)
  • K051121 — DIRECT LDL CHOLESTEROL, MODEL L530-60H (August 8, 2005)
  • K043264 — LDL-EX SEIKEN ASSAY KIT (January 26, 2005)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)
  • K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND P (August 25, 2004)

FDA data resources