Cleared Traditional

MODIFICATION MICRO-MIC

K884510 · Analytical Products, Inc. · Microbiology
Nov 1988
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K884510 is an FDA 510(k) clearance for the MODIFICATION MICRO-MIC, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on November 22, 1988, 26 days after receiving the submission on October 27, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K884510 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1988
Decision Date November 22, 1988
Days to Decision 26 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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