TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200— 510(k) K033383
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K033383 for TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200, Substantially Equivalent on 2003-12-23. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- 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
- San Diego, CA, US
Recent devices under product code NBC
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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 K033383.
Data sourced from openFDA. This site is unofficial and independent of the FDA.