ASSAY SYSTEM, GAMMAFLO, AUTOMATED
FDA 510(k) clearance K781659 · decided 1978-10-24
Clearance details
- K-number
- K781659
- Device name
- ASSAY SYSTEM, GAMMAFLO, AUTOMATED
- Applicant
- E. R. Squibb & Sons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-28
- Decision date
- 1978-10-24
- Days to decision
- 26 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.