BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM— 510(k) K090409
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K090409 for BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, Substantially Equivalent on 2009-05-08. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code MXJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, WA, US
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Adverse events under product code MXJ
product code MXJ- Injury
- 139
- Total
- 139
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.