Cleared Traditional

ROTACLONE ROTAVIRUS DIAGNOSTIC KIT

K852969 · Cambridge Bioscience Corp. · Microbiology
Nov 1985
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K852969 is an FDA 510(k) clearance for the ROTACLONE ROTAVIRUS DIAGNOSTIC KIT, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Cambridge Bioscience Corp. (Hopkinton, US). The FDA issued a Cleared decision on November 5, 1985, 113 days after receiving the submission on July 15, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K852969 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1985
Decision Date November 05, 1985
Days to Decision 113 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