I-STAT CREATINE KINASE MB (CK-MB)
FDA 510(k) clearance K051433 · decided 2005-12-15
Clearance details
- K-number
- K051433
- Device name
- I-STAT CREATINE KINASE MB (CK-MB)
- Applicant
- I-Stat Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-06-01
- Decision date
- 2005-12-15
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- MYT
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Windsor, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOCENTREX CARDIAC PANEL (K033155) | Biocentrex | 2004-01-12 |
| QUANTECH CK-MB ASSAY (K984433) | Quantech , Ltd. | 1999-11-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diag recall (Z-2171-2012) | Abbott Point Of Care Inc. | 2012-08-09 |
| i-STAT cTnl cartridge Abbott Point of Care, Princeton, NJ 08540 recall (Z-0317-2011) | Abbott Point Of Care Inc. | 2010-11-03 |
| i-STAT CK-MB cartridge Abbott Point of Care, Princeton, NJ 08540 recall (Z-0318-2011) | Abbott Point Of Care Inc. | 2010-11-03 |