510(k) K811746
K811746 is an FDA 510(k) premarket notification submitted by King Diagnostics, Inc. for the device "KING DIAGNOSTICS CHOLESTEROL-FE TEST". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code CHO (Radioimmunoassay, Cyclic Amp), a Class II device regulated under 21 CFR 862.1230. King Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1981
- Date Received
- June 22, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Cyclic Amp
- Device Class
- Class II
- Regulation Number
- 862.1230
- Review Panel
- CH
- Submission Type