Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 Mcg/Ml)

Q: What is the product code of K062290?

The FDA product code is LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.

FDA 510(k) K062290 · Dade Behring, Inc.

Substantially Equivalent

510(k) numberK062290

Submission

Device name: Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 Mcg/Ml)
Applicant: Dade Behring, Inc.
West Sacramento, CA, US
Received: August 7, 2006
Decision date: September 1, 2006
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.1640
Specialty: Microbiology

Other 510(k)s with product code LRG

510(k)	Device	Applicant	Decision
K191918	Thermo Scientific Sensititre ARIS HiQ SystemLRG · Traditional	Thermo Fisher Scientific	11/06/2019SE
K191914	Thermo Scientific Sensititre ARIS HiQ SystemLRG · Traditional	Thermo Fisher Scientific	11/06/2019SE
K110583	Sensititre OptireadLRG · Traditional	Trek Diagnostic Systems, Ltd.	09/22/2011SE
K103532	Autoreader 2LRG · Traditional	Trek Diagnostic Systems	08/26/2011SE
K111677	Microscan(R) Microstrep Plus(R)LRG · Traditional	Siemens Healthcare Diagnostics, Inc.	08/04/2011SE
K111205	Microscan (R) Microstrep Plus (R) PanelsLRG · Traditional	Siemens Healthcare Diagnostics, Inc.	07/20/2011SE
K101425	Microscan Dried Gram-Negative Mic/Combo Panel, B1017 Panel SeriesLRG · Traditional	Siemens Healthcare Diagnostics	09/10/2010SE
K081013	Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test Cefoxitin ScreenLRG · Traditional	Siemens Healthcare Diagnostics	09/08/2008SE
K071316	Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Streptomycin…LRG · Traditional	Dade Behring, Inc.	08/20/2007SE
K063299	Microscan Microstrep Plus Panel-ClarithromycinLRG · Traditional	Dade Behring, Inc.	11/27/2006SE

More from Dade Behring, Inc.

510(k)	Device	Decision
K093848	Pt-Multi-Calibrator, Model OPAT07GGN · Traditional	12/20/2010SE
K081161	Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…CFN · Traditional	07/28/2008SE
K081249	Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…DEB · Traditional	07/21/2008SE
K071603	Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional	06/25/2008SE
K071597	Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional	06/04/2008SE
K073604	Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge…CEC · Traditional	03/13/2008SE
K073561	Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…CFN · Traditional	02/26/2008SE
K073072	Dimension Ahdl Flex Reagent Cartridge, Model: DF48BJHM · Traditional	02/21/2008SE
K073055	Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional	01/03/2008SE
K072965	Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional	12/21/2007SE

Questions and answers

When was Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 Mcg/Ml) cleared by the FDA?

Microscan Microstrep Plus Panel Vancomycin (0.06 - 8 Mcg/Ml) (K062290) received a 510(k) decision of Substantially Equivalent on September 1, 2006, 25 days after the submission was received.

What is the product code of K062290?

The FDA product code is LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.