Cleared Traditional

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

K101425 · Siemens Healthcare Diagnostics · Microbiology
Sep 2010
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K101425 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES, a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II — Special Controls, product code LRG), submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on September 10, 2010, 113 days after receiving the submission on May 20, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K101425 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2010
Decision Date September 10, 2010
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

Similar Devices — LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 44
Thermo Scientific Sensititre ARIS HiQ System
K191914 · Thermo Fisher Scientific · Nov 2019
Thermo Scientific Sensititre ARIS HiQ System
K191918 · Thermo Fisher Scientific · Nov 2019
SENSITITRE OPTIREAD
K110583 · Trek Diagnostic Systems, Ltd. · Sep 2011
AUTOREADER 2
K103532 · Trek Diagnostic Systems · Aug 2011
MICROSCAN(R) MICROSTREP PLUS(R)
K111677 · Siemens Healthcare Diagnostics, Inc. · Aug 2011
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
K111205 · Siemens Healthcare Diagnostics, Inc. · Jul 2011

More from Siemens Healthcare Diagnostics

View all
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
K243570 · JLW · Apr 2025
ADVIA 2120i, ADVIA 2120
K162977 · GKZ · Aug 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG · Mar 2017
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
K161954 · JGS · Mar 2017
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
K162538 · JIT · Nov 2016