ARCHITECT STAT TROPONIN-I IMMUNOASSAY
FDA 510(k) clearance K041192 · decided 2004-08-12
Clearance details
- K-number
- K041192
- Device name
- ARCHITECT STAT TROPONIN-I IMMUNOASSAY
- Applicant
- Fisher Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2004-05-06
- Decision date
- 2004-08-12
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- MMI
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Middletown, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro di recall (Z-1509-2012) | Abbott Laboratories | 2012-05-10 |
| ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test recall (Z-0855-2007) | Abbott Laboratories MPG | 2007-06-14 |
| ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles recall (Z-0513-06) | Abbott Laboratories MPG | 2006-02-14 |