ROCHE REAGENT FOR C02— 510(k) K911838
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K911838 for ROCHE REAGENT FOR C02, Substantially Equivalent on 1991-07-19. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code CHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
Recent devices under product code CHS
view allMore clearances from Roche Diagnostic Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.