510(k) K003969
K003969 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS CA 125 II CALSET". The FDA issued a decision of Substantially Equivalent on January 12, 2001. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2001
- Date Received
- December 22, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Primary
- Device Class
- Class II
- Regulation Number
- 862.1150
- Review Panel
- CH
- Submission Type