Product code LET— Clinical Toxicology
AMES TDA PHENOBARBITAL TEST
- Classification name
- Fluorescent Immunoassay, Phenobarbital
- Device class
- Class 2
- Regulation
- 21 CFR 862.3660
- Advisory panel
- Clinical Toxicology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code LET
FDA has cleared devices under product code LET between 1980 and 1990, filed by 6 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
- 1990
- 1987
- 1984
- 1983
- 1982
- 1981
- 1980
Top applicants under product code LET
Recent clearances under product code LET
- K901537 — MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
- K865000 — IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS
- K842592 — AMES TDA PHENOBARBITAL TEST
- K830701 — STRATUS PHENOBARBITAL FLUOROMETRIC ENZ
- K821408 — PHENOBARBITAL FLUORESCENT IMMUNO
- K820188 — PHENOBARBITAL ASSAY
- K810994 — AMES TDA TM PHENOBARBITAL TEST
- K802255 — AMES TDA PHENOBARBITAL TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.