Cleared Traditional

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

K955448 · Behring Diagnostics, Inc. · Toxicology
Feb 1996
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K955448 is an FDA 510(k) clearance for the EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS, a Radioimmunoassay, Lsd (125-i) (Class II — Special Controls, product code DLB), submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on February 23, 1996, 86 days after receiving the submission on November 29, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3580.

Submission Details

510(k) Number K955448 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1995
Decision Date February 23, 1996
Days to Decision 86 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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