Home / 510(k) Clearances / K132711

510(k) K132711

CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT by Carolina Liquid Chemistries Corp. — Product Code LBS

K132711 is an FDA 510(k) premarket notification submitted by Carolina Liquid Chemistries Corp. for the device "CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT". The FDA issued a decision of Substantially Equivalent on May 8, 2014. 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. Carolina Liquid Chemistries Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2014
Date Received
August 29, 2013
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 Carolina Liquid Chemistries Corp.

  • K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (C (January 27, 2022)
  • K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMIS (May 16, 2014)
  • K972073 — TOTAL BILIRUBIN REAGENT (June 24, 1997)
  • K971907 — CALCIUM REAGENT (June 24, 1997)
  • K971324 — TRIGLYCERIDES, TG, OR TRIG (June 20, 1997)
  • K971908 — CREA OR CREATININE (June 17, 1997)
  • K971967 — BUN (June 17, 1997)
  • K971467 — SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (June 16, 1997)
  • K971345 — CHOL OR CHOLESTEROL (May 29, 1997)
  • K971396 — CK REAGENT (May 29, 1997)

Other clearances for product code LBS

  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • 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)
  • K073497 — HDL CHOLESTEROL REAGENT, MODEL 10211 (April 14, 2008)

FDA data resources