Cleared Traditional

PHENYLALANINE (NINHYDRIN REACTION)

K891070 · Alpkem Corp. · Chemistry

Oct 1989

Decision

240d

Days

Class 2

Risk

About This 510(k) Submission

K891070 is an FDA 510(k) clearance for the PHENYLALANINE (NINHYDRIN REACTION), a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on October 27, 1989, 240 days after receiving the submission on March 1, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K891070 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1989
Decision Date	October 27, 1989
Days to Decision	240 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

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