I-STAT CREATINE KINASE MB (CK-MB)— 510(k) K051433
Substantially EquivalentI-Stat Corporation
FDA 510(k) clearance K051433 for I-STAT CREATINE KINASE MB (CK-MB), Substantially Equivalent on 2005-12-15. Applicant: I-Stat Corporation. Device class: 2.
Clearance details
- Applicant
- I-Stat Corporation
- Product code
- Code MYT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Windsor, NJ, US
Recent devices under product code MYT
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view all- K053597 — I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
- K053110 — Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
- K031873 — I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
- K023582 — I-STAT KAOLIN ACT TEST
- K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST
Recalls naming K051433
K-number listed on FDA's recall record- Z-0761-2020 — i-STAT cTnI cartridge
- Z-2171-2012 — i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051433.
Data sourced from openFDA. This site is unofficial and independent of the FDA.