WEST NILE VIRUS ELISA IGG, MODEL EL0300G— 510(k) K031953
Substantially EquivalentFocus Technologies, Inc.
FDA 510(k) clearance K031953 for WEST NILE VIRUS ELISA IGG, MODEL EL0300G, Substantially Equivalent on 2003-10-22. Applicant: Focus Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Focus Technologies, Inc.
- Product code
- Code NOP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3940
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code NOP
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view allRecalls naming K031953
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 K031953.
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