Cleared Traditional

MICRODILUTION MIC PANELS

K863776 · American Micro Scan · Microbiology
Feb 1987
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K863776 is an FDA 510(k) clearance for the MICRODILUTION MIC 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 February 2, 1987, 130 days after receiving the submission on September 25, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K863776 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1986
Decision Date February 02, 1987
Days to Decision 130 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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