510(k) K812235
K812235 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "GOLD(AU 195) SPOT MARKER SOURCES". The FDA issued a decision of Substantially Equivalent on September 9, 1981. The device falls under product code IXD (Source, Calibration, Sealed, Nuclear), a Class I device regulated under 21 CFR 892.1400. Amersham Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1981
- Date Received
- August 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Source, Calibration, Sealed, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1400
- Review Panel
- RA
- Submission Type