ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE— 510(k) K830479
Substantially EquivalentHoffmann-La Roche, Inc.
FDA 510(k) clearance K830479 for ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE, Substantially Equivalent on 1983-03-10. Applicant: Hoffmann-La Roche, Inc.. Device class: 2.
Clearance details
- Applicant
- Hoffmann-La Roche, Inc.
- Product code
- Code DKN
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code DKN
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