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510(k) K023582

I-STAT KAOLIN ACT TEST by I-Stat Corporation — Product Code JBP

K023582 is an FDA 510(k) premarket notification submitted by I-Stat Corporation for the device "I-STAT KAOLIN ACT TEST". The FDA issued a decision of Substantially Equivalent on September 8, 2003. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. I-Stat Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2003
Date Received
October 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
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)
  • K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST (September 2, 2003)
  • K020355 — I-STAT PROTHROMBIN TIME TEST (May 14, 2002)

Other clearances for product code JBP

  • K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (January 4, 2023)
  • K062604 — RAPIDTEG TEG-ACT TEST (January 31, 2007)
  • K032952 — AIACT KIT (December 12, 2003)
  • K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (May 23, 2002)
  • K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (January 10, 2002)
  • K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER O (August 31, 2000)
  • K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (March 28, 2000)
  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYST (January 14, 2000)
  • K984141 — GBACT + KIT (May 28, 1999)

FDA data resources