I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)— 510(k) K053597
Substantially EquivalentI-Stat Corporation
FDA 510(k) clearance K053597 for I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP), Substantially Equivalent on 2006-07-21. Applicant: I-Stat Corporation. Device class: 2.
Clearance details
- Applicant
- I-Stat Corporation
- Product code
- Code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Windsor, NJ, US
Recent devices under product code NBC
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Recalls naming K053597
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053597.
Data sourced from openFDA. This site is unofficial and independent of the FDA.