ClearanceBrief
Panels › Microbiology › Product code LRG · Class 2

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Regulation 866.1640

0510(k)s in 12 months (45 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
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Top companies in LRG

Company510(k)sRecalls
Dade Behring, Inc.230
Beckman Coulter Inc.011
Siemens Healthcare Diagnostics41
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Trek Diagnostic Systems30
Alamar Biosciences, Inc.20
Alamar Biosciences Laboratory, Inc.20
Baxter Healthcare Corp20
Thermo Fisher Scientific20
Analytical Products, Inc.10
DateFirm and productCodeLinked 510(k)
Mar 19, 2025Remel, Inc
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
Open, Classified		 LRGK191918
Dec 2, 2020Beckman Coulter Inc.
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-
Terminated		 LRGK043545
Oct 21, 2019Beckman Coulter Inc.
MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R
Open, Classified		 LRGK911400
Oct 21, 2019Beckman Coulter Inc.
MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
Open, Classified		 LRGK911400
Oct 21, 2019Beckman Coulter Inc.
DxM 1096 MicroScan WalkAway Instrument REF B1018-496
Open, Classified		 LRGK911400
Oct 21, 2019Beckman Coulter Inc.
DxM 1040 MicroScan WalkAway Instrument REF B1018-440
Open, Classified		 LRGK911400
Oct 21, 2019Beckman Coulter Inc.
MicroScan WalkAway-96 plus Instrument REF B1018-284
Open, Classified		 LRGK911400
Oct 21, 2019Beckman Coulter Inc.
MicroScan WalkAway-40 plus Instrument REF B1018-283
Open, Classified		 LRGK911400
Sep 4, 2019Beckman Coulter Inc.
MicroScan WalkAway-96 plus Reconditioned Instrument
Terminated		 LRGK911400
Sep 4, 2019Beckman Coulter Inc.
MicroScan WalkAway-40 plus Reconditioned Instrument
Terminated		 LRGK911400
Sep 4, 2019Beckman Coulter Inc.
MicroScan WalkAway-96 plus Instrument
Terminated		 LRGK911400
Sep 4, 2019Beckman Coulter Inc.
MicroScan WalkAway-40 plus Instrument
Terminated		 LRGK911400
Jul 2, 2014Siemens Healthcare Diagnostics, Inc.
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
Terminated		 LRGK911400

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