TRIAGE TOX DRUG SCREEN— 510(k) K043242
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K043242 for TRIAGE TOX DRUG SCREEN, Substantially Equivalent on 2005-02-28. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code LDP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3030
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code LDP
view allMore clearances from Biosite Incorporated
view allAdverse events under product code LDP
product code LDP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K043242
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 K043242.
Data sourced from openFDA. This site is unofficial and independent of the FDA.