HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200— 510(k) K080322
Substantially EquivalentHycor Biomedical, Inc.
FDA 510(k) clearance K080322 for HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200, Substantially Equivalent on 2008-03-05. 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
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