510(k) K894527
- Device
- FPR PHENYTOIN KIT
- Applicant
- COLONY LABORATORIES, INC.
- 510(k) number
- K894527
- Product code
- DLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-09-25
- Date received
- 1989-07-20
- Regulation
- 862.3350
- Classification name
- Radioimmunoassay, Diphenylhydantoin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE B HINSON
- Address
- 1220 Nineteenth St., NW Fourth Floor Washington DC US 20036 20036
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DLP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K811775 | KALLESTAD ANTISERA TO PHENYTOIN | Kallestad Laboratories, Inc. | 1981-07-10 |
| K792640 | FLUOROMATIC PHENYTOIN FIA | Bio-Rad | 1980-01-11 |
| K791896 | CENTRIA PHENYTOIN RIA TEST SET | Ventrex Laboratories, Inc. | 1979-10-17 |
| K770779 | PHENYTOIN RIA KIT | Amersham Corp. | 1977-06-17 |
Legacy Summary#
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FDA Review#
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