ACCESS SPECIFIC IGE ASSAY— 510(k) K935876
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K935876 for ACCESS SPECIFIC IGE ASSAY, Substantially Equivalent on 1994-03-11. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, 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
- Chaska, MN, US
Recent devices under product code DHB
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