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510(k) K821192

YSI #24 & 24M GLUCOSE ANALYZERS by Yellow Springs Instrument Co., Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
April 27, 1982
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.

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  • 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)
  • K891480 — YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER (May 22, 1989)
  • K883793 — DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) (November 21, 1988)
  • K865012 — YSI MODEL 801 (March 4, 1987)

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