510(k) K771525
- Device
- 125 I DIGOXIN RIA KIT
- Applicant
- Diagnostic Products Corp.
- 510(k) number
- K771525
- Product code
- DPB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-10-14
- Date received
- 1977-08-08
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
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 DPB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K853021 | OPTIMATE DIGOXIN TEST | Miles Laboratories, Inc. | 1985-08-07 |
| K823014 | DIGOXIN KIT | Pcl-Ria, Inc. | 1982-11-01 |
| K821811 | 125I DIGOXIN RADIOIMMUNOASSAY KIT | Cambridge Medical Technology | 1982-07-02 |
| K820274 | DIGOXIN RADIOIMMUNOASSAY | American Diagnostic Corp. | 1982-02-23 |
| K792153 | DIGOXIN RADIOIMMUNOASSAY SYSTEM | Radioimmunoassay, Inc. | 1979-11-13 |
| K790602 | RIA, DIGNXIN-125-I | Endocrine-Metabolic Center | 1979-07-30 |
| K790540 | RIA TEST KIT, CENTRIA DIGOXIN | Ventrex Laboratories, Inc. | 1979-04-23 |
| K772306 | 125I DIGOXIN TEST SET | Wien Laboratories, Inc. | 1977-12-22 |
| K760883 | DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY | Nuclear Medical Laboratories, Inc. | 1976-11-19 |