Home / 510(k) Clearances / K051433

510(k) K051433

I-STAT CREATINE KINASE MB (CK-MB) by I-Stat Corporation — Product Code MYT

K051433 is an FDA 510(k) premarket notification submitted by I-Stat Corporation for the device "I-STAT CREATINE KINASE MB (CK-MB)". The FDA issued a decision of Substantially Equivalent on December 15, 2005. The device falls under product code MYT (Biosensor, Immunoassay, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. I-Stat Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2005
Date Received
June 1, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biosensor, Immunoassay, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
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)
  • 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)
  • K020355 — I-STAT PROTHROMBIN TIME TEST (May 14, 2002)

Other clearances for product code MYT

  • K033155 — BIOCENTREX CARDIAC PANEL (January 12, 2004)
  • K984433 — QUANTECH CK-MB ASSAY (November 1, 1999)

FDA data resources