TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
FDA 510(k) clearance K052789 · decided 2006-01-23
Clearance details
- K-number
- K052789
- Device name
- TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2005-10-03
- Decision date
- 2006-01-23
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model recall (Z-1540-2014) | Alere San Diego, Inc. | 2014-05-02 |