I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
FDA 510(k) clearance K053597 · decided 2006-07-21
Clearance details
- K-number
- K053597
- Device name
- I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
- Applicant
- I-Stat Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-12-23
- Decision date
- 2006-07-21
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- NBC
- Device class
- 2
- Regulation number
- 862.1117
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnos recall (Z-2170-2012) | Abbott Point Of Care Inc. | 2012-08-09 |
| i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540 recall (Z-0319-2011) | Abbott Point Of Care Inc. | 2010-11-03 |