Cleared Traditional

PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS

K853554 · Kallestad Laboratories, Inc. · Microbiology
Nov 1985
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K853554 is an FDA 510(k) clearance for the PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS, 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 November 26, 1985, 92 days after receiving the submission on August 26, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K853554 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1985
Decision Date November 26, 1985
Days to Decision 92 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