125I-IGE RADIOIMMUNOASSAY KIT— 510(k) K801019
Substantially EquivalentBio-Ria
FDA 510(k) clearance K801019 for 125I-IGE RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1980-05-20. Applicant: Bio-Ria. Device class: 2.
Clearance details
- Applicant
- Bio-Ria
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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