Cleared Traditional

VTEC-RPLA SEIKEN

K981734 · Denka Seiken'S · Microbiology

Sep 1998

Decision

127d

Days

Class 1

Risk

About This 510(k) Submission

K981734 is an FDA 510(k) clearance for the VTEC-RPLA SEIKEN, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Denka Seiken'S (Tokyo, JP). The FDA issued a Cleared decision on September 22, 1998, 127 days after receiving the submission on May 18, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number	K981734 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1998
Decision Date	September 22, 1998
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF