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510(k) K901131

YSI MODEL 1500 SPORT L-LACTATE ANALYZER by Yellow Springs Instrument Co., Inc. — Product Code KHP

K901131 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI MODEL 1500 SPORT L-LACTATE ANALYZER". The FDA issued a decision of SN on August 27, 1990. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 27, 1990
Date Received
March 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Lactic, Enzymatic Method
Device Class
Class I
Regulation Number
862.1450
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)
  • 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)
  • K853551 — YSI MODEL 790 TELE-THERMOMETER (September 19, 1985)

Other clearances for product code KHP

  • K130113 — PICCOLO LACTATE TEST SYSTEM (March 11, 2013)
  • K113216 — RAPIDPOINT 500 BLOOD GAS ANALYER (May 3, 2012)
  • K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM (January 5, 2012)
  • K112430 — I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE (December 20, 2011)
  • K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS (August 17, 2011)
  • K093297 — EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE (June 9, 2010)
  • K013938 — IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE (January 28, 2002)
  • K011478 — I-STAT SYSTEM (July 2, 2001)
  • K980908 — LACTATE PRO SYSTEM (September 11, 1998)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)

FDA data resources