EMIT DIGOKIN ASSAY
FDA 510(k) clearance K760709 · decided 1976-10-21
Clearance details
- K-number
- K760709
- Device name
- EMIT DIGOKIN ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1976-09-24
- Decision date
- 1976-10-21
- Days to decision
- 27 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 |
|---|---|---|
| DCA DIGOX-SYN RIA TEST (K810477) | Diagnostic Corp. of America | 1981-03-11 |
| IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. (K803045) | American Dade | 1980-12-22 |
| DIGOXIN RIA (PEG) KIT (K781335) | Ortho Diagnostics, Inc. | 1978-08-31 |
| 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.