Cleared Traditional

CEDIA DAU EDDP ASSAY

K980746 · Boehringer Mannheim Corp. · Toxicology
May 1998
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K980746 is an FDA 510(k) clearance for the CEDIA DAU EDDP ASSAY, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on May 26, 1998, 89 days after receiving the submission on February 26, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K980746 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1998
Decision Date May 26, 1998
Days to Decision 89 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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