DCA DIGOX-SYN RIA TEST
FDA 510(k) clearance K810477 · decided 1981-03-11
Clearance details
- K-number
- K810477
- Device name
- DCA DIGOX-SYN RIA TEST
- Applicant
- Diagnostic Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 1981-02-23
- Decision date
- 1981-03-11
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DOG
- 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 |
|---|---|---|
| IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (K803045) | American Dade | 1980-12-22 |
| DIGOXIN RIA (PEG) KIT (K781335) | Ortho Diagnostics, Inc. | 1978-08-31 |
| EMIT DIGOKIN ASSAY (K760709) | Syva Co. | 1976-10-21 |
| DATA-TOPE SYSTEM DIGOXIN RIA (K760416) | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-23 |
Recalls involving this device
No recalls on record reference this clearance.