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510(k) K011478

I-STAT SYSTEM by I-Stat Corp. — Product Code KHP

K011478 is an FDA 510(k) premarket notification submitted by I-Stat Corp. for the device "I-STAT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 2, 2001. The device falls under product code KHP (Acid, Lactic, Enzymatic Method), a Class I device regulated under 21 CFR 862.1450. I-Stat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2001
Date Received
May 14, 2001
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 I-Stat Corp.

  • K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER (August 20, 2001)
  • K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (October 5, 2000)
  • K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER (April 18, 2000)
  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)
  • K973292 — I-STAT SYSTEM (October 20, 1997)
  • K940918 — I-STAT 200 PORTABLE CLINICAL ANALYZER (May 10, 1994)
  • K936081 — I-STAT TESTS FOR ACID-BASE PARAMETERS (February 24, 1994)
  • K934642 — I-STAT IONIZED CALCIUM TEST (December 17, 1993)
  • K934641 — I-STAT CONTROL LEVELS 1,2,3 (December 9, 1993)

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)
  • K980908 — LACTATE PRO SYSTEM (September 11, 1998)
  • K982071 — I-STAT LACTATE TEST (June 29, 1998)
  • K971944 — LACTEST I (December 17, 1997)

FDA data resources