HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950— 510(k) K071510
Substantially EquivalentFocus Diagnostics, Inc.
FDA 510(k) clearance K071510 for HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950, Substantially Equivalent on 2007-09-24. Applicant: Focus Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Focus Diagnostics, Inc.
- 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
- Cypress, CA, US
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- K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
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.