Product code DKH— Clinical Toxicology

ANTICONVULSANTS III CALIBRATOR KIT

Classification name: Gas Chromatography, Diphenylhydantoin
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Total cleared: 2
First cleared: 1978-06-22
Most recent: 1980-06-20

Market context for product code DKH

FDA has cleared 2 devices under product code DKH between 1978 and 1980, filed by 2 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

19801 clearance
19781 clearance

Top applicants under product code DKH

Vitek Systems, Inc.1 clearance
E.I. Dupont DE Nemours & Co., Inc.1 clearance

Recent clearances under product code DKH

K801276 — DUPONT PREP APPLI. FOR PHENOBARBITAL,E.I. Dupont DE Nemours & Co., Inc.·1980-06-20
K780733 — ANTICONVULSANTS III CALIBRATOR KITVitek Systems, Inc.·1978-06-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.