Atlas FDA

LTT

50 FDA 510(k) clearances · Product code

77 daysmedian time to decision
209 days90th percentile
50clearances measured

FDA profile

Official device name
Panels, Test, Susceptibility, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2005: 24 · 2006: 19 · 2007: 7 · 2008: 4 · 2014: 9 · 2015: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804)Beckman Coulter, Inc.2025-08-20
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (K250036)Beckman Coulter, Inc.2025-08-15
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (K250084)Beckman Coulter, Inc.2025-07-18
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) (K202343)Beckman Coulter, Inc.2020-11-16
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K201423)Beckman Coulter, Inc.2020-06-29
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) (K193536)Beckman Coulter, Inc.2020-03-18
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) (K193358)Beckman Coulter, Inc.2020-03-03
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) (K183127)Beckman Coulter, Inc.2019-02-12
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) (K172337)Beckman Coulter, Inc.2017-12-15
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) (K172912)Beckman Coulter, Inc.2017-12-07
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) (K172255)Beckman Coulter, Inc.2017-12-01
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) (K162740)Beckman Coulter, Inc.2017-03-21
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) (K150039)Siemens Healthcare Diagnostics, Inc.2015-07-02
MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS (K131275)Siemens Helathcare Diagnostics, Inc.2013-11-08
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE (K123933)Siemens Healthcare Diagnostics, Inc.2013-03-14
MICROSCAN MICROSTEP (K111394)Siemens Healthcare Diagnostics, Inc.2011-06-22
MICROSCAN MICROSTREP PLUS, MODEL B1027-201 (K091949)Siemens Healthcare Diagnostics2010-01-26
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 (K091264)Siemens Healthcare Diagnostics2009-07-22
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) (K083262)Siemens Healthcare Diagnostics2009-02-18
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN (K062773)Dade Behring, Inc.2006-10-13
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN (K062777)Dade Behring, Inc.2006-10-10
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) (K033940)Dade Behring, Inc.2004-02-25
PASCO MIC AND MIC/ID PANELS (K030620)Pasco Laboratories, Inc.2003-04-14
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K024357)Trek Diagnostic Systems, Inc.2003-03-17
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K024353)Trek Diagnostic Systems, Inc.2003-03-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN (K021184)Dade Microscan, Inc.2002-06-20
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN (K021078)Dade Microscan, Inc.2002-06-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME (K021111)Dade Microscan, Inc.2002-06-06
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE (K020939)Dade Microscan, Inc.2002-05-17
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN (K020627)Dade Microscan, Inc.2002-05-06
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN (K020626)Dade Microscan, Inc.2002-04-26
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN (K020160)Dade Behring, Inc.2002-03-14
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K013368)Trek Diagnostic Systems, Inc.2001-11-20
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES (K013195)Trek Diagnostic Systems, Inc.2001-11-07
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K010418)Dade Behring, Inc.2001-08-22
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K010159)Dade Microscan, Inc.2001-07-27
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST (K011116)Pasco Laboratories, Inc.2001-04-24
PASCO MIC AND MIC/ID PANELS (K010508)Pasco Laboratories, Inc.2001-04-23
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K003619)Dade Microscan, Inc.2001-01-09
PASCO MIC AND MIC/ID PANELS (K001721)Pasco Laboratories, Inc.2000-08-04
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K993102)Dade Microscan, Inc.1999-12-02
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN (K983306)Accumed Intl., Inc.1998-12-18
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN (K983309)Accumed Intl., Inc.1998-12-14
PASCO MIC AND MIC/ID PANELS (K973317)Pasco Laboratories, Inc.1997-11-14
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K972799)Dade Microscan, Inc.1997-10-10
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K962150)Dade Intl., Inc.1996-08-16
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (K960366)Accumed Intl., Inc.1996-04-09
DRIED GRAM-NEGATIVE MIC//COMBO PANELS (K935704)Baxter Diagnostics, Inc.1995-04-14
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K945235)Baxter Diagnostics, Inc.1995-03-07
DRIED GRAM-NEGATIVE CEFPODOXIME (K941030)Baxter Diagnostics, Inc.1995-02-16

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Every clearance here is in the API, with alerts when new ones post.