510(k) K910222
K910222 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS ALPHA". The FDA issued a decision of Substantially Equivalent on February 27, 1991. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1991
- Date Received
- January 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry, Centrifugal, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2140
- Review Panel
- CH
- Submission Type