DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO— 510(k) K850574
Substantially EquivalentAmerican Dade
FDA 510(k) clearance K850574 for DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO, Substantially Equivalent on 1985-04-12. Applicant: American Dade. Device class: 1.
Clearance details
- Applicant
- American Dade
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
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