Cleared Traditional

ACCUWELL PHENYLALANINE ASSAY

K974047 · Neometrics, Inc. · Chemistry

Dec 1997

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K974047 is an FDA 510(k) clearance for the ACCUWELL PHENYLALANINE ASSAY, a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on December 5, 1997, 42 days after receiving the submission on October 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K974047 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 1997
Decision Date	December 05, 1997
Days to Decision	42 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