Cleared Traditional

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

K031965 · Remel, Inc. · Microbiology

Nov 2003

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K031965 is an FDA 510(k) clearance for the XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Remel, Inc. (Ramsey, US). The FDA issued a Cleared decision on November 14, 2003, 141 days after receiving the submission on June 26, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number	K031965 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2003
Decision Date	November 14, 2003
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF