Product code LES— Clinical Toxicology
AMES TDA TM PHENYTOIN TEST
- Classification name
- Fluorescent Immunoassay, Diphenylhydantoin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code LES
FDA has cleared devices under product code LES between 1980 and 1987, filed by 5 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
- 1987
- 1985
- 1983
- 1982
- 1981
- 1980
Top applicants under product code LES
Recent clearances under product code LES
- K865102 — IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
- K844990 — SYVA ADVANCE EMIT PHENYTOIN ASSAY
- K831154 — STRATUS PHENYTOIN FLUOROMETRIC ENZYME
- K820187 — SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY
- K813538 — PHENYTOIN FLUORESCENT IMMUNOASSAY
- K811025 — AMES TDA TM PHENYTOIN TEST
- K801736 — AMES TDA TM PHENYTOIN TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.