OPTIGEN ALLERGEN SPECIFIC IGE ASSAY— 510(k) K051677
Substantially EquivalentHitachi Chemical Diagnostics, Inc.
FDA 510(k) clearance K051677 for OPTIGEN ALLERGEN SPECIFIC IGE ASSAY, Substantially Equivalent on 2006-01-23. Applicant: Hitachi Chemical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Hitachi Chemical Diagnostics, Inc.
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code DHB
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view allRecalls naming K051677
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 K051677.
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