Cleared Traditional

MICRODILUTION IDENTIFICATION PANELS

K864674 · American Micro Scan · Microbiology
Jan 1987
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K864674 is an FDA 510(k) clearance for the MICRODILUTION IDENTIFICATION PANELS, a Culture Media, Multiple Biochemical Test (Class I — General Controls, product code JSE), submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on January 5, 1987, 34 days after receiving the submission on December 2, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K864674 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 1986
Decision Date January 05, 1987
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSE — Culture Media, Multiple Biochemical Test
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320