510(k) K803045
- Device
- Immu-trace Digoxin (125i) Radioimmun.
- Applicant
- AMERICAN DADE
- 510(k) number
- K803045
- Product code
- DOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-12-22
- Date received
- 1980-12-01
- 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 |
|---|---|---|---|
| K810477 | DCA DIGOX-SYN RIA TEST | Diagnostic Corp. of America | 1981-03-11 |
| 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 |