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510(k) K001154

I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER by I-Stat Corp. — Product Code JGS

K001154 is an FDA 510(k) premarket notification submitted by I-Stat Corp. for the device "I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER". The FDA issued a decision of Substantially Equivalent on April 18, 2000. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. I-Stat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2000
Date Received
April 10, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by I-Stat Corp.

  • K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER (August 20, 2001)
  • K011478 — I-STAT SYSTEM (July 2, 2001)
  • K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 (October 5, 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 JGS

  • K252475 — ABL90 FLEX PLUS System (May 1, 2026)
  • K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl) (July 25, 2023)
  • K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (July 20, 2023)
  • K213486 — GLP systems Track (March 10, 2022)
  • K200403 — Stat Profile Prime Plus Analyzer System (April 14, 2020)
  • K183688 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K191365 — Stat Profile Prime ES Comp Plus Analyzer System (July 19, 2019)
  • K172232 — LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS (June 12, 2019)
  • K183549 — GEM Premier ChemSTAT (February 16, 2019)

FDA data resources