510(k) K791128
K791128 is an FDA 510(k) premarket notification submitted by Institut National Des Radioelements for the device "PTH RIA 200". The FDA issued a decision of Substantially Equivalent on September 27, 1979. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Institut National Des Radioelements has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1979
- Date Received
- June 18, 1979
- 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