I-STAT PROTHROMBIN TIME TEST
FDA 510(k) clearance K020355 · decided 2002-05-14
Clearance details
- K-number
- K020355
- Device name
- I-STAT PROTHROMBIN TIME TEST
- Applicant
- I-Stat Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-02-04
- Decision date
- 2002-05-14
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- 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 PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouche recall (Z-2361-2015) | Abbott Point Of Care Inc. | 2015-08-10 |
| Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat recall (Z-0451-2014) | Abbott Point Of Care Inc. | 2013-12-04 |
| I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge recall (Z-2157-2012) | Abbott Point Of Care Inc. | 2012-08-08 |
| i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ recall (Z-1996-2010) | Abbott Point of Care Inc. | 2010-07-13 |
| i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Ref 04J50-01 24 IVD Abb recall (Z-0364-2007) | Abbott Point of Care Inc. | 2007-01-23 |