Cleared Traditional

DRIED GRAM-NEGATIVE CEFPODOXIME

K941030 · Baxter Diagnostics, Inc. · Microbiology
Feb 1995
Decision
349d
Days
Class 2
Risk

About This 510(k) Submission

K941030 is an FDA 510(k) clearance for the DRIED GRAM-NEGATIVE CEFPODOXIME, a Panels, Test, Susceptibility, Antimicrobial (Class II — Special Controls, product code LTT), submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on February 16, 1995, 349 days after receiving the submission on March 4, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K941030 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 1994
Decision Date February 16, 1995
Days to Decision 349 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LTT — Panels, Test, Susceptibility, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

Similar Devices — LTT Panels, Test, Susceptibility, Antimicrobial

All 49
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 ?g/mL) (MicroScan)
K243804 · Beckman Coulter, Inc. · Aug 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 ?g/mL)
K250036 · Beckman Coulter, Inc. · Aug 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 ?g/mL)
K250084 · Beckman Coulter, Inc. · Jul 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ?g/mL )
K202343 · Beckman Coulter, Inc. · Nov 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ?g/mL)
K201423 · Beckman Coulter, Inc. · Jun 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8?g/mL)
K193536 · Beckman Coulter, Inc. · Mar 2020