510(k) K812235
- Device
- GOLD(AU 195) SPOT MARKER SOURCES
- Applicant
- AMERSHAM CORP.
- 510(k) number
- K812235
- Product code
- IXD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-09
- Date received
- 1981-08-11
- Regulation
- 892.1400
- Classification name
- Source, Calibration, Sealed, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010244786
- 3034521
- 1034973
- 9681124
- 2032766
- 1062620
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IXD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Syncor Intl. Corp. | 1985-03-26 |
Legacy Summary#
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FDA Review#
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