Cleared Traditional

PRECEPT(TM) CIPROFLOXACIN

K874727 · Austin Biological Laboratories · Microbiology
Feb 1988
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K874727 is an FDA 510(k) clearance for the PRECEPT(TM) CIPROFLOXACIN, 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 February 18, 1988, 92 days after receiving the submission on November 18, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K874727 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1987
Decision Date February 18, 1988
Days to Decision 92 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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