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510(k) K133519

CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR by Carolina Liquid Chemistries Corp. — Product Code JJE

K133519 is an FDA 510(k) premarket notification submitted by Carolina Liquid Chemistries Corp. for the device "CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR". The FDA issued a decision of Substantially Equivalent on May 16, 2014. The device falls under product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use), a Class I device regulated under 21 CFR 862.2160. Carolina Liquid Chemistries Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2014
Date Received
November 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
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)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 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 JJE

  • K183375 — Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, (February 12, 2019)
  • K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (May 15, 2014)
  • K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( (January 9, 2014)
  • K130276 — DIMENSION EXL WITH LM SYSTEM (March 22, 2013)
  • K113253 — ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGEN (May 17, 2012)
  • K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM (November 22, 2011)
  • K110035 — INDIKO (June 28, 2011)
  • K073370 — TC MATRIX CLINICAL CHEMISTRY ANALYZER (May 8, 2008)
  • K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM (November 13, 2006)
  • K051087 — DIMENSION VISTA INTEGRATED SYSTEM (July 11, 2005)

FDA data resources