Cleared Traditional

RIM E.COLI 0157:H7 LATEX TEST

K933457 · Remel Co. · Microbiology

Apr 1994

Decision

280d

Days

Class 1

Risk

About This 510(k) Submission

K933457 is an FDA 510(k) clearance for the RIM E.COLI 0157:H7 LATEX TEST, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on April 20, 1994, 280 days after receiving the submission on July 14, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number	K933457 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1993
Decision Date	April 20, 1994
Days to Decision	280 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement