Cleared Traditional

QUANTASE PHE/GAL SCREENING ASSAY

K984463 · Quantase , Ltd. · Chemistry

Feb 1999

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K984463 is an FDA 510(k) clearance for the QUANTASE PHE/GAL SCREENING ASSAY, a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Quantase , Ltd. (Perth, Scotland, GB). The FDA issued a Cleared decision on February 16, 1999, 62 days after receiving the submission on December 16, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K984463 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 1998
Decision Date	February 16, 1999
Days to Decision	62 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