510(k) K053533
K053533 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corporation for the device "IMMULITE/IMMULITE 1000 TURBO INTACT PTH". The FDA issued a decision of Substantially Equivalent on February 3, 2006. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Diagnostic Products Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2006
- Date Received
- December 19, 2005
- Clearance Type
- Traditional
- 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