Cleared Traditional

NYSTYMOGRAPH ACCESS

K823111 · Kelleher Corp. · Microbiology
Nov 1982
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K823111 is an FDA 510(k) clearance for the NYSTYMOGRAPH ACCESS, a Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6 (Class I — General Controls, product code GNN), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982, 28 days after receiving the submission on October 25, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3145.

Submission Details

510(k) Number K823111 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1982
Decision Date November 22, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GNN — Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3145