Cleared Traditional

NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT

K021541 · Perkinelmer Life Sciences · Chemistry

Oct 2002

Decision

171d

Days

Class 2

Risk

About This 510(k) Submission

K021541 is an FDA 510(k) clearance for the NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT, a Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (Class II — Special Controls, product code JNB), submitted by Perkinelmer Life Sciences (Norton, US). The FDA issued a Cleared decision on October 28, 2002, 171 days after receiving the submission on May 10, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1555.

Submission Details

510(k) Number	K021541 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2002
Decision Date	October 28, 2002
Days to Decision	171 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

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