FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
FDA 510(k) clearance K850208 · decided 1985-03-26
Clearance details
- K-number
- K850208
- Device name
- FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
- Applicant
- Syncor Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-18
- Decision date
- 1985-03-26
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- IXD
- Device class
- 1
- Regulation number
- 892.1400
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sylmar, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GOLD(AU 195) SPOT MARKER SOURCES (K812235) | Amersham Corp. | 1981-09-09 |
Recalls involving this device
No recalls on record reference this clearance.