510(k) K830701
- Device
- Stratus Phenobarbital Fluorometric Enz
- Applicant
- AMERICAN DADE
- 510(k) number
- K830701
- Product code
- LET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-13
- Date received
- 1983-03-07
- Regulation
- 862.3660
- Classification name
- Fluorescent Immunoassay, Phenobarbital
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LET#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901537 | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1990-06-12 |
| K865000 | IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS | Sclavo, Inc. | 1987-02-06 |
| K842592 | AMES TDA PHENOBARBITAL TEST | Miles Laboratories, Inc. | 1984-08-17 |
| K821408 | PHENOBARBITAL FLUORESCENT IMMUNO | American Diagnostic Corp. | 1982-05-24 |
| K820188 | PHENOBARBITAL ASSAY | Syva Co. | 1982-02-05 |
| K810994 | AMES TDA TM PHENOBARBITAL TEST | Miles Laboratories, Inc. | 1981-04-29 |
| K802255 | AMES TDA PHENOBARBITAL TEST | Miles Laboratories, Inc. | 1980-09-26 |