Cleared Traditional

NEOLYNX SCREENING APPLICATION MANAGER

K003584 · Micromass, Inc. · Chemistry

Mar 2001

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K003584 is an FDA 510(k) clearance for the NEOLYNX SCREENING APPLICATION MANAGER, a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Micromass, Inc. (Milford, US). The FDA issued a Cleared decision on March 19, 2001, 119 days after receiving the submission on November 20, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K003584 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2000
Decision Date	March 19, 2001
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	JNB — Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1555