Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)

K-Number: K201423 · 2020-06-29

ApplicantBeckman Coulter, Inc.
Decision Date2020-06-29
Product CodeLTT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2020-06-29 under approval number K201423. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)?

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) is a medical device that received FDA 510(k) clearance on 2020-06-29. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K201423.

When was MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) approved by the FDA?

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) received FDA 510(k) clearance on 2020-06-29, under approval number K201423.

What company makes MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)?

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) is manufactured by Beckman Coulter, Inc..

What is the FDA product code for MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)?

The FDA product code for MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) is LTT.

Related Clinical Trials

NCT05378399 SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder COMPLETED

Other Devices by Beckman Coulter, Inc.

K161837ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

View all 77 devices →

Related Devices (Code: LTT)

K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)Beckman Coulter, Inc. K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)Beckman Coulter, Inc. K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)Beckman Coulter, Inc. K162740MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)Beckman Coulter, Inc. K183127MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)Beckman Coulter, Inc. K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑