510(k) K810477
- Device
- Dca Digox-syn Ria Test
- Applicant
- DIAGNOSTIC CORP. OF AMERICA
- 510(k) number
- K810477
- Product code
- DOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-11
- Date received
- 1981-02-23
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DOG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K803045 | IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. | American Dade | 1980-12-22 |
| K781335 | DIGOXIN RIA (PEG) KIT | Ortho Diagnostics, Inc. | 1978-08-31 |
| K760709 | EMIT DIGOKIN ASSAY | Syva Co. | 1976-10-21 |
| K760416 | DATA-TOPE SYSTEM DIGOXIN RIA | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-23 |