Cleared Traditional

AGGLUTEX BARBITURATES TEST KIT

K812988 · Hoffmann-La Roche, Inc. · Toxicology
Dec 1981
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K812988 is an FDA 510(k) clearance for the AGGLUTEX BARBITURATES TEST KIT, a Radioimmunoassay, Barbiturate (Class II — Special Controls, product code DKN), submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981, 66 days after receiving the submission on October 26, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K812988 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1981
Decision Date December 31, 1981
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKN — Radioimmunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150