Home / 510(k) Clearances / K112430

510(k) K112430

I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE by Abbott Pont of Care, Inc. — Product Code KHP

K112430 is an FDA 510(k) premarket notification submitted by Abbott Pont of Care, Inc. for the device "I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE". The FDA issued a decision of Substantially Equivalent on December 20, 2011. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2011
Date Received
August 24, 2011
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 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)
  • 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)
  • K971944 — LACTEST I (December 17, 1997)

FDA data resources