Cleared Traditional

ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)

K962745 · Prepared Media Laboratory, Inc. · Microbiology

Oct 1996

Decision

79d

Days

Class 1

Risk

About This 510(k) Submission

K962745 is an FDA 510(k) clearance for the ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000), a Culture Media, Propagating Transport (Class I — General Controls, product code JSN), submitted by Prepared Media Laboratory, Inc. (Portland, US). The FDA issued a Cleared decision on October 2, 1996, 79 days after receiving the submission on July 15, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number	K962745 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 1996
Decision Date	October 02, 1996
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement