Cleared Traditional

WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000

K982307 · Wallac, Inc. · Chemistry

Feb 1999

Decision

216d

Days

Class 2

Risk

About This 510(k) Submission

K982307 is an FDA 510(k) clearance for the WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000, a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Wallac, Inc. (Norton, US). The FDA issued a Cleared decision on February 2, 1999, 216 days after receiving the submission on July 1, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K982307 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 1998
Decision Date	February 02, 1999
Days to Decision	216 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement

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