Cleared Traditional

K864069 - PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID
(FDA 510(k) Clearance)

K864069 · Austin Biological Laboratories · Microbiology
Nov 1986
Decision
24d
Days
Class 2
Risk

K864069 is an FDA 510(k) clearance for the PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on November 13, 1986, 24 days after receiving the submission on October 20, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K864069 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1986
Decision Date November 13, 1986
Days to Decision 24 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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