Cleared Traditional

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

K000754 · Quantase , Ltd. · Chemistry

Jun 2000

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K000754 is an FDA 510(k) clearance for the QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT, 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 June 19, 2000, 103 days after receiving the submission on March 8, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K000754 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2000
Decision Date	June 19, 2000
Days to Decision	103 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