Cleared Traditional

ASIMANAGER - AT (K111356) - FDA 510(k) Clearance

Class I Microbiology device.

K111356 · Arlington Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
177d
Days
Class 1
Risk

K111356 is an FDA 510(k) clearance for the ASIMANAGER - AT. Classified as Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (product code JQT), Class I - General Controls.

Submitted by Arlington Scientific, Inc. (Springville, US). The FDA issued a Cleared decision on November 9, 2011 after a review of 177 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2400 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Arlington Scientific, Inc. devices

Submission Details

510(k) Number K111356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date November 09, 2011
Days to Decision 177 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 102d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.