Cleared Traditional

K950817 - DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
(FDA 510(k) Clearance)

K950817 · Baxter Diagnostics, Inc. · Microbiology
Apr 1995
Decision
62d
Days
Class 2
Risk

K950817 is an FDA 510(k) clearance for the DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI, 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 April 25, 1995, 62 days after receiving the submission on February 22, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K950817 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1995
Decision Date April 25, 1995
Days to Decision 62 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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