Cleared Traditional

ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE

K823212 · Hoffmann-La Roche, Inc. · Chemistry
Nov 1982
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K823212 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE, a Radioimmunoassay, Amphetamine (Class II — Special Controls, product code DJP), submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982, 32 days after receiving the submission on October 28, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K823212 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1982
Decision Date November 29, 1982
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DJP — Radioimmunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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