FDA 510(k) Applications for Medical Device Product Code "LTT"
(Panels, Test, Susceptibility, Antimicrobial)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K960366 | ACCUMED INTL., INC. | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES | 04/09/1996 |
| K983306 | ACCUMED INTL., INC. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN | 12/18/1998 |
| K983309 | ACCUMED INTL., INC. | SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN | 12/14/1998 |
| K172912 | Beckman Coulter Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 û 8 ╡g/mL) | 12/07/2017 |
| K172255 | Beckman Coulter, Inc | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) | 12/01/2017 |
| K193536 | Beckman Coulter, Inc | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8╡g/mL) | 03/18/2020 |
| K172337 | Beckman Coulter, Inc. | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) | 12/15/2017 |
| K183127 | Beckman Coulter, Inc. | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) | 02/12/2019 |
| K202343 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ╡g/mL ) | 11/16/2020 |
| K162740 | BECKMAN COULTER, INC. | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) | 03/21/2017 |
| K193358 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) | 03/03/2020 |
| K201423 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ╡g/mL) | 06/29/2020 |
| K010418 | DADE BEHRING, INC. | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | 08/22/2001 |
| K020160 | DADE BEHRING, INC. | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN | 03/14/2002 |
| K033940 | DADE BEHRING, INC. | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) | 02/25/2004 |
| K062777 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN | 10/10/2006 |
| K062773 | DADE BEHRING, INC. | MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN | 10/13/2006 |
| K962150 | DADE INTL., INC. | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | 08/16/1996 |
| K010159 | DADE MICROSCAN, INC. | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS | 07/27/2001 |
| K003619 | DADE MICROSCAN, INC. | DRIED GRAM-POSITIVE MIC/COMBO PANELS | 01/09/2001 |
| K972799 | DADE MICROSCAN, INC. | DRIED GRAM-POSITIVE MIC/COMBO PANELS | 10/10/1997 |
| K993102 | DADE MICROSCAN, INC. | DRIED GRAM-POSITIVE MIC/COMBO PANELS | 12/02/1999 |
| K021111 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME | 06/06/2002 |
| K021184 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN | 06/20/2002 |
| K021078 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN | 06/06/2002 |
| K020627 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN | 05/06/2002 |
| K020626 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN | 04/26/2002 |
| K020939 | DADE MICROSCAN, INC. | MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE | 05/17/2002 |
| K001721 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 08/04/2000 |
| K010508 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 04/23/2001 |
| K030620 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 04/14/2003 |
| K973317 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS | 11/14/1997 |
| K011116 | PASCO LABORATORIES, INC. | PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST | 04/24/2001 |
| K083262 | SIEMENS HEALTHCARE DIAGNOSTICS | MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) | 02/18/2009 |
| K091264 | SIEMENS HEALTHCARE DIAGNOSTICS | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 | 07/22/2009 |
| K091949 | SIEMENS HEALTHCARE DIAGNOSTICS | MICROSCAN MICROSTREP PLUS, MODEL B1027-201 | 01/26/2010 |
| K150039 | Siemens Healthcare Diagnostics Inc. | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) | 07/02/2015 |
| K111394 | Siemens Healthcare Diagnostics Inc. | MICROSCAN MICROSTEP | 06/22/2011 |
| K123933 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE | 03/14/2013 |
| K131275 | SIEMENS HELATHCARE DIAGNOSTICS INC. | MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS | 11/08/2013 |
| K013368 | TREK DIAGNOSTIC SYSTEMS, INC. | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE | 11/20/2001 |
| K013195 | TREK DIAGNOSTIC SYSTEMS, INC. | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES | 11/07/2001 |
| K024357 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES | 03/17/2003 |
| K024353 | TREK DIAGNOSTIC SYSTEMS, INC. | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | 03/06/2003 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
