510(k) K941878
K941878 is an FDA 510(k) premarket notification submitted by I.D.S. for the device "OCTEIA INTACT PTH". The FDA issued a decision of Substantially Equivalent on Sep 7, 1994. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 7, 1994
- Date Received
- Apr 18, 1994
- 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
- 510(k)