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510(k) K020355

I-STAT PROTHROMBIN TIME TEST by I-Stat Corporation — Product Code GJS

K020355 is an FDA 510(k) premarket notification submitted by I-Stat Corporation for the device "I-STAT PROTHROMBIN TIME TEST". The FDA issued a decision of Substantially Equivalent on May 14, 2002. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. I-Stat Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2002
Date Received
February 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances by I-Stat Corporation

  • K053597 — I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) (July 21, 2006)
  • K053110 — Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartri (January 13, 2006)
  • K051433 — I-STAT CREATINE KINASE MB (CK-MB) (December 15, 2005)
  • K031873 — I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VE (October 7, 2003)
  • K023582 — I-STAT KAOLIN ACT TEST (September 8, 2003)
  • K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST (September 2, 2003)

Other clearances for product code GJS

  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K251564 — microINR System (July 21, 2025)
  • K243543 — microINR System (February 27, 2025)
  • K230802 — Xprecia Prime Coagulation System (March 15, 2024)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K231711 — microINR System (July 11, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (October 5, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
  • K201185 — microINR System (December 18, 2020)

FDA data resources