Cleared Traditional

GRAM NEGATIVE COMBO PANEL TYPE 3

K861584 · American Micro Scan · Microbiology
Jun 1986
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K861584 is an FDA 510(k) clearance for the GRAM NEGATIVE COMBO PANEL TYPE 3, 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 June 17, 1986, 49 days after receiving the submission on April 29, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K861584 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1986
Decision Date June 17, 1986
Days to Decision 49 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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