Cleared Traditional

INPOUCH-TV POUCH

K896296 · Biomed Diagnostics, Inc. · Microbiology

Jan 1990

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K896296 is an FDA 510(k) clearance for the INPOUCH-TV POUCH, a Culture Media, Propagating Transport (Class I — General Controls, product code JSN), submitted by Biomed Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on January 29, 1990, 90 days after receiving the submission on October 31, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number	K896296 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 1989
Decision Date	January 29, 1990
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—