Cleared Traditional

K991697 - UNI-GOLD H. PYLORI
(FDA 510(k) Clearance)

K991697 · Trinity Biotech, Plc · Microbiology

Dec 1999

Decision

217d

Days

Class 1

Risk

K991697 is an FDA 510(k) clearance for the UNI-GOLD H. PYLORI, a Helicobacter Pylori (Class I — General Controls, product code LYR), submitted by Trinity Biotech, Plc (Los Angeles, US). The FDA issued a Cleared decision on December 21, 1999, 217 days after receiving the submission on May 18, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K991697 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1999
Decision Date	December 21, 1999
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF