Cleared Traditional

ALADIN (TM)

K865062 · Analytical Products, Inc. · Microbiology

Mar 1987

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K865062 is an FDA 510(k) clearance for the ALADIN (TM), a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II — Special Controls, product code LRG), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on March 25, 1987, 91 days after receiving the submission on December 24, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K865062 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 24, 1986
Decision Date	March 25, 1987
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

Device Classification

Product Code	LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640