Cleared Traditional

PATHFINDER ROTAVIRUS CHEMILUMINESCENT

K862917 · Kallestad Laboratories, Inc. · Microbiology
Oct 1986
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K862917 is an FDA 510(k) clearance for the PATHFINDER ROTAVIRUS CHEMILUMINESCENT, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 22, 1986, 82 days after receiving the submission on August 1, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K862917 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1986
Decision Date October 22, 1986
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405