510(k) K864612
- Device
- DART PHENOBARBITAL ASSAY SYSTEM
- Applicant
- COULTER ELECTRONICS, INC.
- 510(k) number
- K864612
- Product code
- LFN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-13
- Date received
- 1986-11-24
- Regulation
- 862.3660
- Classification name
- Nephelometric Inhibition Immunoassay, Phenobarbital
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARDSON-JONES
- Address
- 440 W. 20 St. Hialeah FL US 33010 33010
FDA Registration Numbers#
- 2050012
- 2050010
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 |
| K860303 | DUPONT PHENOBARBITAL CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| K860304 | DUPONT PHENOBARBITAL ASSAY | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| K821543 | IPA FOR DETECTION OF PHENOBARBITAL | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 |
Legacy Summary#
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FDA Review#
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