510(k) K792640
- Device
- Fluoromatic Phenytoin Fia
- Applicant
- BIO-RAD
- 510(k) number
- K792640
- Product code
- DLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-11
- Date received
- 1979-12-27
- Regulation
- 862.3350
- Classification name
- Radioimmunoassay, Diphenylhydantoin
- 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 DLP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894527 | FPR PHENYTOIN KIT | Colony Laboratories, Inc. | 1989-09-25 |
| K811775 | KALLESTAD ANTISERA TO PHENYTOIN | Kallestad Laboratories, Inc. | 1981-07-10 |
| K791896 | CENTRIA PHENYTOIN RIA TEST SET | Ventrex Laboratories, Inc. | 1979-10-17 |
| K770779 | PHENYTOIN RIA KIT | Amersham Corp. | 1977-06-17 |