Cleared Traditional

PORPHOBILINOGEN (PBG)

K961984 · Trace America, Inc. · Chemistry

Dec 1996

Decision

203d

Days

Class 1

Risk

About This 510(k) Submission

K961984 is an FDA 510(k) clearance for the PORPHOBILINOGEN (PBG), a Ion-exchange Resin, Ehrlich's Reagent, Porphobilinogen (Class I — General Controls, product code JNF), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on December 10, 1996, 203 days after receiving the submission on May 21, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1590.

Submission Details

510(k) Number	K961984 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 1996
Decision Date	December 10, 1996
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement