GASTRIN RADIOIMMUNOASSAY TEST KIT
FDA 510(k) clearance K842965 · decided 1984-10-11
Clearance details
- K-number
- K842965
- Device name
- GASTRIN RADIOIMMUNOASSAY TEST KIT
- Applicant
- Serono Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-27
- Decision date
- 1984-10-11
- Days to decision
- 76 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Bramtree, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.