AGGLUTEX MORPHINE TEST KIT— 510(k) K812985
Substantially EquivalentHoffmann-La Roche, Inc.
FDA 510(k) clearance K812985 for AGGLUTEX MORPHINE TEST KIT, Substantially Equivalent on 1981-12-31. Applicant: Hoffmann-La Roche, Inc.. Device class: 1.
Clearance details
- Applicant
- Hoffmann-La Roche, Inc.
- Product code
- Code DDF
- Device class
- Class 1
- Regulation
- 21 CFR 866.5735
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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