TEST, RIA, SERUM DIGOXIN
FDA 510(k) clearance K760077 · decided 1976-07-16
Clearance details
- K-number
- K760077
- Device name
- TEST, RIA, SERUM DIGOXIN
- Applicant
- Smithkline Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-18
- Decision date
- 1976-07-16
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DND
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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.