510(k) K860304
- Device
- Dupont Phenobarbital Assay
- Applicant
- E.I. DUPONT DE NEMOURS & CO., INC.
- 510(k) number
- K860304
- Product code
- LFN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-28
- Date received
- 1986-01-28
- Regulation
- 862.3660
- Classification name
- Nephelometric Inhibition Immunoassay, Phenobarbital
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD M VAUGHT
- Address
- Medical Products Dept. Barley Mill Plz., P22-1170 Wilmington DE US 19898 19898
FDA Registration Numbers#
- 2050010
- 2050012
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934388 | QMS PHENOBARBITAL | Seradyn, Inc. | 1994-02-25 |
| K864612 | DART PHENOBARBITAL ASSAY SYSTEM | Coulter Electronics, Inc. | 1987-01-13 |
| K860303 | DUPONT PHENOBARBITAL CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| K821543 | IPA FOR DETECTION OF PHENOBARBITAL | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 |