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510(k) K971133

URIC, UA, OR URIC ACID by Carolina Liquid Chemistries Corp. — Product Code KNK

K971133 is an FDA 510(k) premarket notification submitted by Carolina Liquid Chemistries Corp. for the device "URIC, UA, OR URIC ACID". The FDA issued a decision of Substantially Equivalent on April 14, 1997. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Carolina Liquid Chemistries Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1997
Date Received
March 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Uricase (Colorimetric)
Device Class
Class I
Regulation Number
862.1775
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)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K971907 — CALCIUM REAGENT (June 24, 1997)
  • K972073 — TOTAL BILIRUBIN 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)

Other clearances for product code KNK

  • K102568 — URIC ACID MODEL 3P39 (May 6, 2011)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
  • K012038 — JAS URIC ACID LIQUID REAGENT (August 21, 2001)
  • K010421 — WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X5 (April 13, 2001)
  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)

FDA data resources