510(k) K934388
- Device
- QMS PHENOBARBITAL
- Applicant
- SERADYN, INC.
- 510(k) number
- K934388
- Product code
- LFN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-25
- Date received
- 1993-09-09
- Regulation
- 862.3660
- Classification name
- Nephelometric Inhibition Immunoassay, Phenobarbital
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDRIS INDRIKSONS
- Address
- P.O. Box 1210 Indianapolis IN US 46206 46206
FDA Registration Numbers#
- 2050010
- 2050012
Source Documents#
Other 510(k) Records For Product Code LFN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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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