Cleared Traditional

QUANTASE PHENYLALANINE ASSAY

K961515 · Shield Diagnostics, Ltd. · Chemistry

Jun 1996

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K961515 is an FDA 510(k) clearance for the QUANTASE PHENYLALANINE ASSAY, a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on June 12, 1996, 63 days after receiving the submission on April 10, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K961515 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 1996
Decision Date	June 12, 1996
Days to Decision	63 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