Cleared Traditional

CEDIA DAU LSD ASSAY

K955814 · Microgenics Corp. · Toxicology
Feb 1996
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K955814 is an FDA 510(k) clearance for the CEDIA DAU LSD ASSAY, a Radioimmunoassay, Lsd (125-i) (Class II — Special Controls, product code DLB), submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on February 9, 1996, 45 days after receiving the submission on December 26, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3580.

Submission Details

510(k) Number K955814 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1995
Decision Date February 09, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLB — Radioimmunoassay, Lsd (125-i)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3580

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