I-STAT KAOLIN ACT TEST
FDA 510(k) clearance K023582 · decided 2003-09-08
Clearance details
- K-number
- K023582
- Device name
- I-STAT KAOLIN ACT TEST
- Applicant
- I-Stat Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-10-24
- Decision date
- 2003-09-08
- Days to decision
- 319 days
- Clearance type
- Traditional
- Product code
- JBP
- Device class
- 2
- Regulation number
- 864.7140
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- East Windsor, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to moni recall (Z-0400-2011) | Abbott Point Of Care Inc. | 2010-11-17 |
| Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood recall (Z-0814-2010) | Abbott Point of Care Inc. | 2010-02-23 |