510(k) K920829
K920829 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS CORE FERRITIN EIA". The FDA issued a decision of Substantially Equivalent on June 19, 1992. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 1992
- Date Received
- February 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Device Class
- Class II
- Regulation Number
- 866.5340
- Review Panel
- CH
- Submission Type