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510(k) K040971

GENCHEM ISE ELECTROLYTE REFERENCE by Genchem, Inc. — Product Code JGS

K040971 is an FDA 510(k) premarket notification submitted by Genchem, Inc. for the device "GENCHEM ISE ELECTROLYTE REFERENCE". The FDA issued a decision of Substantially Equivalent on December 22, 2004. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Genchem, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2004
Date Received
April 14, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
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)
  • K040974 — GLUCOSE OXIDASE, GLUCOSE (December 27, 2004)
  • K040976 — GENCHEM CREATININE REAGENT (December 27, 2004)

Other clearances for product code JGS

  • K252475 — ABL90 FLEX PLUS System (May 1, 2026)
  • K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl) (July 25, 2023)
  • K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (July 20, 2023)
  • K213486 — GLP systems Track (March 10, 2022)
  • K200403 — Stat Profile Prime Plus Analyzer System (April 14, 2020)
  • K183688 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K191365 — Stat Profile Prime ES Comp Plus Analyzer System (July 19, 2019)
  • K172232 — LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS (June 12, 2019)
  • K183549 — GEM Premier ChemSTAT (February 16, 2019)

FDA data resources