510(k) K043318
K043318 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 23, 2004. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2004
- Date Received
- December 2, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Folic, Radioimmunoassay
- Device Class
- Class II
- Regulation Number
- 862.1295
- Review Panel
- CH
- Submission Type