Cleared Traditional

MANUAL PHENYLALANINE TEST

K963040 · Bio-Rad · Chemistry

Oct 1996

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K963040 is an FDA 510(k) clearance for the MANUAL PHENYLALANINE TEST, a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on October 1, 1996, 57 days after receiving the submission on August 5, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K963040 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 1996
Decision Date	October 01, 1996
Days to Decision	57 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