Cleared Traditional

REVISED DOUBLE ANTIBODY AMPHETAMINE

K882228 · Diagnostic Products Corp. · Toxicology
Aug 1988
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K882228 is an FDA 510(k) clearance for the REVISED DOUBLE ANTIBODY AMPHETAMINE, a Radioimmunoassay, Amphetamine (Class II — Special Controls, product code DJP), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 8, 1988, 81 days after receiving the submission on May 19, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K882228 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1988
Decision Date August 08, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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

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