510(k) K911838
K911838 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE REAGENT FOR C02". The FDA issued a decision of Substantially Equivalent on July 19, 1991. The device falls under product code CHS (Coulometric Method, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1991
- Date Received
- April 25, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coulometric Method, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type