Cleared Traditional

ROTAVIRUS EIA

K964424 · Trinity Biotech, Inc. · Microbiology

Aug 1997

Decision

276d

Days

Class 1

Risk

About This 510(k) Submission

K964424 is an FDA 510(k) clearance for the ROTAVIRUS EIA, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Trinity Biotech, Inc. (Irvine, US). The FDA issued a Cleared decision on August 8, 1997, 276 days after receiving the submission on November 5, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number	K964424 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1996
Decision Date	August 08, 1997
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement