Cleared Traditional

WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254

K023889 · Wiener Laboratories Saic · Microbiology

Feb 2004

Decision

447d

Days

Class 1

Risk

About This 510(k) Submission

K023889 is an FDA 510(k) clearance for the WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254, a Enzyme Linked Immunosorbent Assay, T. Cruzi (Class I — General Controls, product code MIU), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on February 11, 2004, 447 days after receiving the submission on November 21, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3870.

Submission Details

510(k) Number	K023889 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2002
Decision Date	February 11, 2004
Days to Decision	447 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF