Product code LER— Clinical Toxicology
AMES TDA THEOPHYLLINE TEST
- Classification name
- Fluorescent Immunoassay, Theophylline
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Total cleared
- 15
- First cleared
- Most recent
Market context for product code LER
FDA has cleared devices under product code LER between 1981 and 1994, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1994
- 1990
- 1988
- 1986
- 1984
- 1983
- 1982
- 1981
Top applicants under product code LER
Recent clearances under product code LER
- K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
- K905521 — CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
- K882570 — TURBOX THEOPHYLLINE ASSAY
- K864409 — IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
- K863475 — THEOFAST(TM) TEST PACKAGE
- K842585 — THEOPHYLLINE KIT FLUORESCENCE POLARIZA-
- K840758 — IMMPULSE THEOPHYLLINE ASSAY REAGENTS
- K833070 — TDX THEOPHYLLINE
- K831514 — AMWA TDA THEOPHYLLINE TEST
- K823576 — COBAS STANDARD FOR TOTAL PROTEIN
- K820397 — AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
- K813240 — EMIT-AAD THEOPHYLLINE ASSAY
- K812518 — AMES TDA THEOPHYLLINE TEST
- K811856 — FLUOROMATIC THEOPHYLLINE FIA
- K810943 — AMES TDA THEOPHYLLINE TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.