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510(k) K936081

I-STAT TESTS FOR ACID-BASE PARAMETERS by I-Stat Corp. — Product Code CHL

K936081 is an FDA 510(k) premarket notification submitted by I-Stat Corp. for the device "I-STAT TESTS FOR ACID-BASE PARAMETERS". The FDA issued a decision of Substantially Equivalent on February 24, 1994. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. I-Stat Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1994
Date Received
December 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
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)
  • 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)
  • 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 CHL

  • K252207 — ABL90 FLEX PLUS System, safeCLINITUBES (April 10, 2026)
  • K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System (May 2, 2025)
  • K240998 — ABL90 FLEX PLUS System (December 13, 2024)
  • K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K221900 — Stat Profile Prime Plus Analyzer System (September 29, 2023)
  • K223857 — i-STAT G3+ cartridge with the i-STAT 1 System (September 15, 2023)
  • K223608 — GEM Premier 7000 with IQM3 (August 10, 2023)
  • K211559 — EasyStat 300 (January 27, 2023)
  • K203790 — GEM Premier 5000 (August 20, 2021)
  • K200986 — OPTI® B-Lac Cassette (August 2, 2021)

FDA data resources