510(k) K781335
- Device
- DIGOXIN RIA (PEG) KIT
- Applicant
- ORTHO DIAGNOSTICS, INC.
- 510(k) number
- K781335
- Product code
- DOG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-31
- Date received
- 1978-08-02
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol
- Medical specialty
- Toxicology
- Review panel
- Immunology
- 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 |
| K803045 | IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. | American Dade | 1980-12-22 |
| K760709 | EMIT DIGOKIN ASSAY | Syva Co. | 1976-10-21 |
| K760416 | DATA-TOPE SYSTEM DIGOXIN RIA | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-23 |
Legacy Summary#
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FDA Review#
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