510(k) K070391
K070391 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ELECSYS PTH TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 2007. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2007
- Date Received
- February 9, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Parathyroid Hormone
- Device Class
- Class II
- Regulation Number
- 862.1545
- Review Panel
- CH
- Submission Type