LER — Fluorescent Immunoassay, Theophylline Class II
FDA Device Classification
Classification Details
- Product Code
- LER
- Device Class
- Class II
- Regulation Number
- 862.3880
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K942192 | sigma diagnostics | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS | July 13, 1994 |
| K905521 | microgenics | CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION | December 26, 1990 |
| K882570 | unipath | TURBOX THEOPHYLLINE ASSAY | November 10, 1988 |
| K864409 | sclavo | IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS | December 22, 1986 |
| K863475 | 3m | THEOFAST(TM) TEST PACKAGE | November 5, 1986 |
| K842585 | windsor laboratories | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- | September 26, 1984 |
| K840758 | paragon diagnostics | IMMPULSE THEOPHYLLINE ASSAY REAGENTS | April 4, 1984 |
| K833070 | abbott laboratories | TDX THEOPHYLLINE | November 14, 1983 |
| K831514 | miles laboratories | AMWA TDA THEOPHYLLINE TEST | June 30, 1983 |
| K823576 | hoffmann-la roche | COBAS STANDARD FOR TOTAL PROTEIN | January 7, 1983 |
| K820397 | american diagnostic | AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM | March 2, 1982 |
| K813240 | syva | EMIT-AAD THEOPHYLLINE ASSAY | December 3, 1981 |
| K812518 | miles laboratories | AMES TDA THEOPHYLLINE TEST | September 23, 1981 |
| K811856 | bio-rad | FLUOROMATIC THEOPHYLLINE FIA | July 10, 1981 |
| K810943 | miles laboratories | AMES TDA THEOPHYLLINE TEST | April 17, 1981 |