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510(k) K971467

SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) by Carolina Liquid Chemistries Corp. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
April 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
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)
  • K971967 — BUN (June 17, 1997)
  • K971908 — CREA OR CREATININE (June 17, 1997)
  • K971345 — CHOL OR CHOLESTEROL (May 29, 1997)
  • K971396 — CK REAGENT (May 29, 1997)

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