MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)— 510(k) K043545

Name: FDA 510(k) clearance K043545
Creator: U.S. Food and Drug Administration
Published: 2005-02-17

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K043545 for MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML), Substantially Equivalent on 2005-02-17. Applicant: Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code LRG
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2004-12-23
Decision date: 2005-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K043545

K-number listed on FDA's recall record

Z-0720-2021 — MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.Class II·Terminated·Beckman Coulter Inc.·20201202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043545.

Data sourced from openFDA. This site is unofficial and independent of the FDA.