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)
Top companies in LTT
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 12 | 11 |
| Dade Microscan, Inc. | 10 | 0 |
| Siemens Healthcare Diagnostics | 6 | 2 |
| Dade Behring, Inc. | 5 | 0 |
| Pasco Laboratories, Inc. | 5 | 0 |
| Trek Diagnostic Systems, Inc. | 4 | 0 |
| Accumed Intl., Inc. | 3 | 0 |
| Baxter Diagnostics, Inc. | 3 | 0 |
| Dade Intl., Inc. | 1 | 0 |
| Siemens Helathcare Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2025 | K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) Beckman Coulter, Inc. | LTT |
| Aug 15, 2025 | K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) Beckman Coulter, Inc. | LTT |
| Jul 18, 2025 | K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) Beckman Coulter, Inc. | LTT |
| Nov 16, 2020 | K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) Beckman Coulter, Inc. | LTT |
| Jun 29, 2020 | K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) Beckman Coulter, Inc. | LTT |
| Mar 18, 2020 | K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) Beckman Coulter, Inc. | LTT |
| Mar 3, 2020 | K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) Beckman Coulter, Inc. | LTT |
| Feb 12, 2019 | K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) Beckman Coulter, Inc. | LTT |
| Dec 15, 2017 | K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Beckman Coulter, Inc. | LTT |
| Dec 7, 2017 | K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL) Beckman Coulter, Inc. | LTT |
| Dec 1, 2017 | K172255 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) Beckman Coulter, Inc. | LTT |
| Mar 21, 2017 | K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) Beckman Coulter, Inc. | LTT |
| Jul 2, 2015 | K150039 | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) Siemens Healthcare Diagnostics, Inc. | LTT |
| Nov 8, 2013 | K131275 | MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS Siemens Helathcare Diagnostics, Inc. | LTT |
| Mar 14, 2013 | K123933 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE Siemens Healthcare Diagnostics, Inc. | LTT |
| Jun 22, 2011 | K111394 | MICROSCAN MICROSTEP Siemens Healthcare Diagnostics, Inc. | LTT |
| Jan 26, 2010 | K091949 | MICROSCAN MICROSTREP PLUS, MODEL B1027-201 Siemens Healthcare Diagnostics | LTT |
| Jul 22, 2009 | K091264 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 Siemens Healthcare Diagnostics | LTT |
| Feb 18, 2009 | K083262 | MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) Siemens Healthcare Diagnostics | LTT |
| Oct 13, 2006 | K062773 | MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN Dade Behring, Inc. | LTT |
| Oct 10, 2006 | K062777 | MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN Dade Behring, Inc. | LTT |
| Feb 25, 2004 | K033940 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) Dade Behring, Inc. | LTT |
| Apr 14, 2003 | K030620 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | LTT |
| Mar 17, 2003 | K024357 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | LTT |
| Mar 6, 2003 | K024353 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | LTT |
| Jun 20, 2002 | K021184 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN Dade Microscan, Inc. | LTT |
| Jun 6, 2002 | K021111 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME Dade Microscan, Inc. | LTT |
| Jun 6, 2002 | K021078 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN Dade Microscan, Inc. | LTT |
| May 17, 2002 | K020939 | MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE Dade Microscan, Inc. | LTT |
| May 6, 2002 | K020627 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN Dade Microscan, Inc. | LTT |
| Apr 26, 2002 | K020626 | MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN Dade Microscan, Inc. | LTT |
| Mar 14, 2002 | K020160 | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN Dade Behring, Inc. | LTT |
| Nov 20, 2001 | K013368 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE Trek Diagnostic Systems, Inc. | LTT |
| Nov 7, 2001 | K013195 | HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | LTT |
| Aug 22, 2001 | K010418 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Behring, Inc. | LTT |
| Jul 27, 2001 | K010159 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Apr 24, 2001 | K011116 | PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST Pasco Laboratories, Inc. | LTT |
| Apr 23, 2001 | K010508 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | LTT |
| Jan 9, 2001 | K003619 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Aug 4, 2000 | K001721 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | LTT |
| Dec 2, 1999 | K993102 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Dec 18, 1998 | K983306 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN Accumed Intl., Inc. | LTT |
| Dec 14, 1998 | K983309 | SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN Accumed Intl., Inc. | LTT |
| Nov 14, 1997 | K973317 | PASCO MIC AND MIC/ID PANELS Pasco Laboratories, Inc. | LTT |
| Oct 10, 1997 | K972799 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Dade Microscan, Inc. | LTT |
| Aug 16, 1996 | K962150 | DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS Dade Intl., Inc. | LTT |
| Apr 9, 1996 | K960366 | SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES Accumed Intl., Inc. | LTT |
| Apr 14, 1995 | K935704 | DRIED GRAM-NEGATIVE MIC//COMBO PANELS Baxter Diagnostics, Inc. | LTT |
| Mar 7, 1995 | K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS Baxter Diagnostics, Inc. | LTT |
| Feb 16, 1995 | K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME Baxter Diagnostics, Inc. | LTT |
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