COBAS STANDARDS FOR ALBUMIN— 510(k) K823575
Substantially EquivalentHoffmann-La Roche, Inc.
FDA 510(k) clearance K823575 for COBAS STANDARDS FOR ALBUMIN, Substantially Equivalent on 1983-01-07. Applicant: Hoffmann-La Roche, Inc.. Device class: 2.
Clearance details
- Applicant
- Hoffmann-La Roche, Inc.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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