Home / 510(k) Clearances / K891480

510(k) K891480

YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER by Yellow Springs Instrument Co., Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1989
Date Received
March 17, 1989
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 Yellow Springs Instrument Co., Inc.

  • K962070 — YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE (July 19, 1996)
  • K922821 — YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES (November 23, 1992)
  • K922007 — YSI MODEL 441A AIRWAY TEMPERATURE PROBE (November 4, 1992)
  • K910633 — YSI MODEL 1500 BLOOD GLUCOSE ANALYZER (April 12, 1991)
  • K910718 — YSI PRECISION 4000 THERMOMETER (April 9, 1991)
  • K901131 — YSI MODEL 1500 SPORT L-LACTATE ANALYZER (August 27, 1990)
  • K893409 — YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP (July 20, 1989)
  • K883793 — DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) (November 21, 1988)
  • K865012 — YSI MODEL 801 (March 4, 1987)
  • K853551 — YSI MODEL 790 TELE-THERMOMETER (September 19, 1985)

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)