510(k) K860253
K860253 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code CHO (Radioimmunoassay, Cyclic Amp), a Class II device regulated under 21 CFR 862.1230. Amersham Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1986
- Date Received
- January 24, 1986
- 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