ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
FDA 510(k) clearance K802461 · decided 1980-10-31
Clearance details
- K-number
- K802461
- Device name
- ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
- Applicant
- Immunotech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-08
- Decision date
- 1980-10-31
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- LCW
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walker, MI, 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 |
|---|---|---|
| MATCHED COMPONENT SET FOR DIGITOXIN (K834080) | Cambridge Medical Technology | 1984-02-04 |
| (125 I) DIGITOXIN RIA KIT (K780766) | Diagnostic Products Corp. | 1978-07-27 |
Recalls involving this device
No recalls on record reference this clearance.