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510(k) K040974

GLUCOSE OXIDASE, GLUCOSE by Genchem, Inc. — Product Code CGA

K040974 is an FDA 510(k) premarket notification submitted by Genchem, Inc. for the device "GLUCOSE OXIDASE, GLUCOSE". The FDA issued a decision of Substantially Equivalent on December 27, 2004. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Genchem, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2004
Date Received
April 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Genchem, Inc.

  • K090283 — CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3 (June 5, 2009)
  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • K040977 — GENCHEM ELECTROLYTE BUFFER (December 27, 2004)
  • K040972 — CALCIUM, AZO DYE REAGENT (December 27, 2004)
  • K040973 — BUN REAGENT (December 27, 2004)
  • K040976 — GENCHEM CREATININE REAGENT (December 27, 2004)
  • K040971 — GENCHEM ISE ELECTROLYTE REFERENCE (December 22, 2004)

Other clearances for product code CGA

  • K252488 — ABL90 FLEX PLUS System (May 1, 2026)
  • K210933 — YSI 2900C Biochemistry Analyzer (September 30, 2024)
  • K220328 — EasyStat 300 (July 26, 2024)
  • K223179 — Cholestech LDX ™ System (September 20, 2023)
  • K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)
  • K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System (July 28, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K203549 — Nova Primary Glucose Analyzer System (October 18, 2022)
  • K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)
  • K200349 — Stat Profile Prime Plus Analyzer System (March 13, 2020)

FDA data resources