Cleared Traditional

MICRODILUTION PANELS

K862140 · American Micro Scan · Microbiology
Jul 1986
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K862140 is an FDA 510(k) clearance for the MICRODILUTION PANELS, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on July 16, 1986, 42 days after receiving the submission on June 4, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K862140 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 1986
Decision Date July 16, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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