IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST
FDA 510(k) clearance K780709 · decided 1978-05-12
Clearance details
- K-number
- K780709
- Device name
- IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST
- Applicant
- Clinical Assays, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-26
- Decision date
- 1978-05-12
- Days to decision
- 16 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.