Cleared Traditional

K904738 - PYLORI STAT TEST KIT
(FDA 510(k) Clearance)

K904738 · Whittaker Bioproducts, Inc. · Microbiology

May 1991

Decision

201d

Days

Class 1

Risk

K904738 is an FDA 510(k) clearance for the PYLORI STAT TEST KIT. This device is classified as a Helicobacter Pylori (Class I — General Controls, product code LYR).

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on May 7, 1991, 201 days after receiving the submission on October 18, 1990.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K904738 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 1990
Decision Date	May 07, 1991
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—