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510(k) K971396

CK REAGENT by Carolina Liquid Chemistries Corp. — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1997
Date Received
April 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
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)
  • K972073 — TOTAL BILIRUBIN REAGENT (June 24, 1997)
  • K971907 — CALCIUM REAGENT (June 24, 1997)
  • K971324 — TRIGLYCERIDES, TG, OR TRIG (June 20, 1997)
  • K971967 — BUN (June 17, 1997)
  • K971908 — CREA OR CREATININE (June 17, 1997)
  • K971467 — SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (June 16, 1997)
  • K971345 — CHOL OR CHOLESTEROL (May 29, 1997)

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