510(k) K850254
K850254 is an FDA 510(k) premarket notification submitted by Cambridge Medical Technology for the device "PARATHYROID HORMONE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on Apr 3, 1985. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Cambridge Medical Technology has 13 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 3, 1985
- Date Received
- Jan 22, 1985
- 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)