Cleared Traditional

YEAST IDENTIFICATION PANEL

K860575 · American Micro Scan · Microbiology
May 1986
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K860575 is an FDA 510(k) clearance for the YEAST IDENTIFICATION PANEL, a Kit, Identification, Yeast (Class I — General Controls, product code JXB), submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on May 13, 1986, 84 days after receiving the submission on February 18, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K860575 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1986
Decision Date May 13, 1986
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JXB — Kit, Identification, Yeast
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660