HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM— 510(k) K081217
Substantially EquivalentHycor Biomedical, Inc.
FDA 510(k) clearance K081217 for HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM, Substantially Equivalent on 2008-05-22. Applicant: Hycor Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Hycor Biomedical, 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
- Special
- Location
- Garden Grove, CA, US
Recent devices under product code DHB
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view allRecalls naming K081217
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 K081217.
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