RABBIT ANTIBODY TO DIGOXIN
FDA 510(k) clearance K780316 · decided 1978-03-17
Clearance details
- K-number
- K780316
- Device name
- RABBIT ANTIBODY TO DIGOXIN
- Applicant
- Pcl-Ria, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-24
- Decision date
- 1978-03-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- DKA
- 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 |
|---|---|---|
| STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY (K934003) | Baxter Diagnostics, Inc. | 1994-11-22 |
| CBR-DIGOXIN ANTISERUM (K780498) | Clinical Bioresearch | 1978-04-05 |
Recalls involving this device
No recalls on record reference this clearance.