LER — Fluorescent Immunoassay, Theophylline Class II
FDA product code LER covers "Fluorescent Immunoassay, Theophylline", a Class II medical device regulated under 21 CFR 862.3880. Submissions are reviewed by the Clinical Toxicology panel. At least 15 recent 510(k) clearances have been granted under this product code.
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 |