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510(k) K012478

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER by I-Stat Corp. — Product Code CHL

K012478 is an FDA 510(k) premarket notification submitted by I-Stat Corp. for the device "MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER". The FDA issued a decision of Substantially Equivalent on August 20, 2001. 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
August 20, 2001
Date Received
August 2, 2001
Clearance Type
Special
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.

  • 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)
  • 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 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