ClearanceBrief
Panels › Microbiology › Product code LTT · Class 2

Panels, Test, Susceptibility, Antimicrobial

Regulation 866.1640

0510(k)s in 12 months (50 all time)
3recalls in 12 months (13 all time)
5recalls that name a 510(k)
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Top companies in LTT

Company510(k)sRecalls
Beckman Coulter, Inc.1211
Dade Microscan, Inc.100
Siemens Healthcare Diagnostics62
Dade Behring, Inc.50
Pasco Laboratories, Inc.50
Trek Diagnostic Systems, Inc.40
Accumed Intl., Inc.30
Baxter Diagnostics, Inc.30
Dade Intl., Inc.10
Siemens Helathcare Diagnostics, Inc.10
DateFirm and productCodeLinked 510(k)
Apr 8, 2026Beckman Coulter, Inc.
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panel
Open, Classified		 LTTNone listed
Apr 3, 2026Beckman Coulter, Inc.
MicroScan Neg MIC 3J REF C54814
Open, Classified		 LTTNone listed
Mar 20, 2026Beckman Coulter, Inc.
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerob
Open, Classified		 LTTK202343
May 4, 2018Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultati
Terminated		 LTTK020160
Dec 1, 2015Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the sp
Terminated		 LTTNone listed
Dec 1, 2015Beckman Coulter Inc.
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the sp
Terminated		 LTTNone listed
Dec 1, 2015Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 34, Part No. B1017-214 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level
Terminated		 LTTNone listed
Dec 1, 2015Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 33, Part No. B1017-211 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level
Terminated		 LTTNone listed
Dec 1, 2015Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level
Terminated		 LTTNone listed
Oct 7, 2015Beckman Coulter Inc.
MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of c
Terminated		 LTTK020626
K062773 +2
Oct 7, 2015Beckman Coulter Inc.
MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of c
Terminated		 LTTK020626
K062773 +2
Jun 8, 2013Siemens Healthcare Diagnostics, Inc.
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
Terminated		 LTTNone listed
May 8, 2013Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenteroco
Terminated		 LTTK091949

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