Home / 510(k) Clearances / K842221

510(k) K842221

WAKO GLUCOSE C by Wako Pure Chemical Industries, Ltd. — Product Code CGA

K842221 is an FDA 510(k) premarket notification submitted by Wako Pure Chemical Industries, Ltd. for the device "WAKO GLUCOSE C". The FDA issued a decision of Substantially Equivalent on July 12, 1984. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Wako Pure Chemical Industries, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1984
Date Received
June 5, 1984
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 Wako Pure Chemical Industries, Ltd.

  • K813366 — AMMONIA TEST (December 22, 1981)
  • K801891 — WAKO TRIGLYCERIDE-G TEST (September 16, 1980)
  • K801834 — WAKO HDL CHOLESTEROL TEST (September 16, 1980)
  • K801076 — WAKO PHOSPHOLIPIDS TEST (June 30, 1980)
  • K791597 — WAKO TRIGLYCERIDE (September 17, 1979)

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