Cleared Traditional

NON-FERMENTER SYSTEM

K772112 · Corning Medical & Scientific · Microbiology
Nov 1977
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K772112 is an FDA 510(k) clearance for the NON-FERMENTER SYSTEM, a Kit, Identification, Glucose Nonfermenter (Class I — General Controls, product code JSW), submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on November 17, 1977, 10 days after receiving the submission on November 7, 1977. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K772112 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1977
Decision Date November 17, 1977
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSW — Kit, Identification, Glucose Nonfermenter
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660