510(k) K865102
- Device
- IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
- Applicant
- SCLAVO, INC.
- 510(k) number
- K865102
- Product code
- LES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-13
- Date received
- 1986-12-24
- Regulation
- 862.3350
- Classification name
- Fluorescent Immunoassay, Diphenylhydantoin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL BRINKLEY
- Address
- 1240 Elko Dr. Sunnyvale CA US 94089 94089
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K844990 | SYVA ADVANCE EMIT PHENYTOIN ASSAY | Syva Co. | 1985-01-23 |
| K831154 | STRATUS PHENYTOIN FLUOROMETRIC ENZYME | American Dade | 1983-05-16 |
| K820187 | SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY | Syva Co. | 1982-02-12 |
| K813538 | PHENYTOIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1981-12-31 |
| K811025 | AMES TDA TM PHENYTOIN TEST | Miles Laboratories, Inc. | 1981-04-29 |
| K801736 | AMES TDA TM PHENYTOIN TEST | Miles Laboratories, Inc. | 1980-08-20 |
Legacy Summary#
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FDA Review#
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