Cleared Traditional

K940917 - LORACARBEF GRAM-NAGATIVE PANELS
(FDA 510(k) Clearance)

K940917 · Baxter Diagnostics, Inc. · Microbiology
Feb 1995
Decision
348d
Days
Class 2
Risk

K940917 is an FDA 510(k) clearance for the LORACARBEF GRAM-NAGATIVE PANELS. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY).

Submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on February 8, 1995, 348 days after receiving the submission on February 25, 1994.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K940917 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 1994
Decision Date February 08, 1995
Days to Decision 348 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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