Product code DIW— Clinical Toxicology

HI-M-TEST FOR METHADONE TEST #2

Classification name: Hemagglutination Inhibition, Methadone
Device class: Class 2
Regulation: 21 CFR 862.3620
Advisory panel: Clinical Toxicology
Total cleared: 4
First cleared: 1976-07-20
Most recent: 1995-03-21

Market context for product code DIW

FDA has cleared 4 devices under product code DIW between 1976 and 1995, filed by 4 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

19951 clearance
19931 clearance
19801 clearance
19761 clearance

Top applicants under product code DIW

Technam, Inc.1 clearance
Roche Diagnostic Systems, Inc.1 clearance
J.T. Baker Chemical Co.1 clearance
E.I. Dupont DE Nemours & Co., Inc.1 clearance

Recent clearances under product code DIW

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