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510(k) K021316

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR by Genzyme Corp. — Product Code LBS

K021316 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR". The FDA issued a decision of Substantially Equivalent on July 25, 2002. The device falls under product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl), 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
July 25, 2002
Date Received
April 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
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)
  • 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)
  • K000239 — GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL (March 21, 2000)

Other clearances for product code LBS

  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES (September 7, 2012)
  • K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER (September 27, 2011)
  • K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL (August 31, 2011)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)
  • K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-C (September 28, 2010)
  • K100010 — HDL CHOLESTEROL (HDLX) ASSAY (May 14, 2010)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)

FDA data resources