Panels, Test, Susceptibility, Antimicrobial

LTT 2025-08-15

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)

Applicant Beckman Coulter, Inc.

K number K250036

LTT 2025-07-18

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)

Applicant Beckman Coulter, Inc.

K number K250084

LTT 2020-11-16

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )

Applicant Beckman Coulter, Inc.

K number K202343

LTT 2020-06-29

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

Applicant Beckman Coulter, Inc.

K number K201423

LTT 2020-03-18

MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)

Applicant Beckman Coulter, Inc.

K number K193536

LTT 2020-03-03

MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)

Applicant Beckman Coulter, Inc.

K number K193358

LTT 2019-02-12

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)

Applicant Beckman Coulter, Inc.

K number K183127

LTT 2017-12-15

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)

Applicant Beckman Coulter, Inc.

K number K172337

LTT 2017-12-07

MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)

Applicant Beckman Coulter, Inc.

K number K172912

LTT 2017-12-01

MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

Applicant Beckman Coulter, Inc.

K number K172255

LTT 2017-03-21

MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)

Applicant Beckman Coulter, Inc.

K number K162740

LTT 2013-11-08

MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS

Applicant Siemens Helathcare Diagnostics, Inc.

K number K131275

LTT 2013-03-14

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE

Applicant Siemens Healthcare Diagnostics, Inc.

K number K123933

LTT 2011-06-22

MICROSCAN MICROSTEP

Applicant Siemens Healthcare Diagnostics, Inc.

K number K111394

LTT 2010-01-26

MICROSCAN MICROSTREP PLUS, MODEL B1027-201

Applicant Siemens Healthcare Diagnostics

K number K091949

LTT 2009-07-22

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017

Applicant Siemens Healthcare Diagnostics

K number K091264

LTT 2009-02-18

MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)

Applicant Siemens Healthcare Diagnostics

K number K083262

LTT 2006-10-13

MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN

Applicant Dade Behring, Inc.

K number K062773

LTT 2006-10-10

MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN

Applicant Dade Behring, Inc.

K number K062777

LTT 2004-02-25

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)

Applicant Dade Behring, Inc.

K number K033940

LTT 2003-04-14

PASCO MIC AND MIC/ID PANELS

K number K030620

LTT 2003-03-17

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

K number K024357

LTT 2003-03-06

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

K number K024353

LTT 2002-06-20

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN

Applicant Dade Microscan, Inc.

K number K021184

LTT 2002-06-06

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME

Applicant Dade Microscan, Inc.

K number K021111

LTT 2002-06-06

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN

Applicant Dade Microscan, Inc.

K number K021078

LTT 2002-05-17

MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE

Applicant Dade Microscan, Inc.

K number K020939

LTT 2002-05-06

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN

Applicant Dade Microscan, Inc.

K number K020627

LTT 2002-04-26

MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN

Applicant Dade Microscan, Inc.

K number K020626

LTT 2002-03-14

DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN

Applicant Dade Behring, Inc.

K number K020160

LTT 2001-11-20

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K number K013368

LTT 2001-11-07

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES

K number K013195

LTT 2001-08-22

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Behring, Inc.

K number K010418

LTT 2001-07-27

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Microscan, Inc.

K number K010159

LTT 2001-04-24

PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST

K number K011116

LTT 2001-04-23

PASCO MIC AND MIC/ID PANELS

K number K010508

LTT 2001-01-09

DRIED GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Microscan, Inc.

K number K003619

LTT 2000-08-04

PASCO MIC AND MIC/ID PANELS

K number K001721

LTT 1999-12-02

DRIED GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Microscan, Inc.

K number K993102

LTT 1998-12-18

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN

Applicant Accumed Intl., Inc.

K number K983306

LTT 1998-12-14

SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN

Applicant Accumed Intl., Inc.

K number K983309

LTT 1997-11-14

PASCO MIC AND MIC/ID PANELS

K number K973317

LTT 1997-10-10

DRIED GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Microscan, Inc.

K number K972799

LTT 1996-08-16

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

Applicant Dade Intl., Inc.

K number K962150

LTT 1996-04-09

SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES

Applicant Accumed Intl., Inc.

K number K960366

LTT 1995-04-14

DRIED GRAM-NEGATIVE MIC//COMBO PANELS

Applicant Baxter Diagnostics, Inc.

K number K935704

LTT 1995-03-07

DRIED GRAM-POSITIVE MIC/COMBO PANELS

Applicant Baxter Diagnostics, Inc.

K number K945235

LTT 1995-02-16

DRIED GRAM-NEGATIVE CEFPODOXIME

Applicant Baxter Diagnostics, Inc.

K number K941030