510(k) K885292
K885292 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS MFC". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code JQP (Calculator/Data Processing Module, For Clinical Use), a Class I device regulated under 21 CFR 862.2100. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1989
- Date Received
- December 27, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator/Data Processing Module, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2100
- Review Panel
- CH
- Submission Type