Home / 510(k) Clearances / K781342

510(k) K781342

GLUCOSE TEST by Wako Intl., Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
August 4, 1978
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 Intl., Inc.

  • K790768 — WAKO CHOLESTEROL TEST (May 23, 1979)
  • K781899 — UREA NITROGEN TEST (December 20, 1978)
  • K781629 — SERI-SEP SERUM/PLASMA ISLOLATOR (October 27, 1978)

Other clearances for product code CGA

  • 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)
  • K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)