PLATELIA TOXO IGM KIT MODEL 26211— 510(k) K090847
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K090847 for PLATELIA TOXO IGM KIT MODEL 26211, Substantially Equivalent on 2009-07-01. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code LGD
- Device class
- Class 2
- Regulation
- 21 CFR 866.3780
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Redmond, WA, US
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Adverse events under product code LGD
product code LGD- Malfunction
- 502
- Total
- 502
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 K090847
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 K090847.
Data sourced from openFDA. This site is unofficial and independent of the FDA.