510(k) K831191
- Device
- VASCULAR CATHETER
- Applicant
- MEDRAD, INC.
- 510(k) number
- K831191
- Product code
- DOY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-09
- Date received
- 1983-04-12
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (3-h), Goat Antibody, 2nd Antibody Sep.
- Medical specialty
- Toxicology
- Review panel
- 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
FDA Registration Numbers#
- 1058584
- 3015859709
- 2520313
- 3011334555
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DOY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910154 | USCI ILLUMEN-8 8F PTCA GUIDING CATHETER | C.R. Bard, Inc. | 1991-04-09 |
| K832396 | CENTRAL VENOUS ACCESS CATHETER CVAC | Gish Biomedical, Inc. | 1983-08-31 |
| K831239 | WALRUS PERCUTANEOUS INTRODUCER SET | Medical Parameters, Inc. | 1983-05-25 |
| K831188 | CONNECTOR TUBE | Medrad, Inc. | 1983-05-09 |
Legacy Summary#
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FDA Review#
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