DIGOXIN RIA KIT
FDA 510(k) clearance K771533 · decided 1977-08-25
Clearance details
- K-number
- K771533
- Device name
- DIGOXIN RIA KIT
- Applicant
- G.D. Searle and Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-08-10
- Decision date
- 1977-08-25
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DNJ
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| DIGOXIN RIA KIT (K771877) | Antibodies, Inc. | 1977-10-21 |
Recalls involving this device
No recalls on record reference this clearance.