Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRG — Predicate Candidate Screening
45 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
268 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191918 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific | 2019-11-06 | 111 | 1 |
| K191914 | Thermo Scientific Sensititre ARIS HiQ System | Thermo Fisher Scientific | 2019-11-06 | 112 | 0 |
| K110583 | SENSITITRE OPTIREAD | Trek Diagnostic Systems, Ltd. | 2011-09-22 | 205 | 0 |
| K103532 | AUTOREADER 2 | Trek Diagnostic Systems | 2011-08-26 | 268 | 0 |
| K111677 | MICROSCAN(R) MICROSTREP PLUS(R) | Siemens Healthcare Diagnostics, Inc. | 2011-08-04 | 50 | 0 |
| K111205 | MICROSCAN (R) MICROSTREP PLUS (R) PANELS | Siemens Healthcare Diagnostics, Inc. | 2011-07-20 | 82 | 0 |
| K101425 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL S | Siemens Healthcare Diagnostics | 2010-09-10 | 113 | 0 |
| K081013 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICRO | Siemens Healthcare Diagnostics | 2008-09-08 | 152 | 0 |
| K071316 | MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW | Dade Behring, Inc. | 2007-08-20 | 102 | 0 |
| K063299 | MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN | Dade Behring, Inc. | 2006-11-27 | 26 | 0 |
| K063102 | MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) | Dade Behring, Inc. | 2006-11-09 | 30 | 0 |
| K063099 | MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) | Dade Behring, Inc. | 2006-11-01 | 22 | 0 |
| K063101 | MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML | Dade Behring, Inc. | 2006-11-01 | 22 | 0 |
| K063065 | MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) | Dade Behring, Inc. | 2006-10-27 | 21 | 0 |
| K063053 | MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) | Dade Behring, Inc. | 2006-10-26 | 22 | 0 |
| K063064 | MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) | Dade Behring, Inc. | 2006-10-26 | 20 | 0 |
| K062375 | MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG | Dade Behring, Inc. | 2006-10-26 | 72 | 0 |
| K062923 | MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MC | Dade Behring, Inc. | 2006-10-13 | 15 | 0 |
| K062927 | MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/M | Dade Behring, Inc. | 2006-10-12 | 14 | 2 |
| K062585 | MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN | Dade Behring, Inc. | 2006-09-19 | 18 | 0 |
| K062596 | MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID | Dade Behring, Inc. | 2006-09-19 | 18 | 0 |
| K062290 | MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) | Dade Behring, Inc. | 2006-09-01 | 25 | 0 |
| K062293 | MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG | Dade Behring, Inc. | 2006-08-24 | 17 | 0 |
| K061872 | MICROSCAN MICROSTREP PLUS PANEL | Dade Behring, Inc. | 2006-08-23 | 51 | 0 |
| K062179 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROM | Dade Behring, Inc. | 2006-08-23 | 23 | 0 |
| K062276 | MICROSCAN MICROSTREP PLUS PANEL | Dade Behring, Inc. | 2006-08-23 | 16 | 0 |
| K053243 | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2006-01-20 | 60 | 0 |
| K050043 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROM | Dade Behring, Inc. | 2005-03-29 | 78 | 0 |
| K050585 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K | Dade Behring, Inc. | 2005-03-18 | 11 | 0 |
| K043545 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYC | Dade Behring, Inc. | 2005-02-17 | 56 | 0 |
| K041150 | MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS | Dade Behring, Inc. | 2004-07-22 | 80 | 0 |
| K033948 | MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN | Dade Behring, Inc. | 2004-03-01 | 73 | 0 |
| K981199 | MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN | Dade Microscan, Inc. | 1998-11-18 | 230 | 0 |
| K941425 | ALAMAR ANTIBIOTIC SUSCEPTIBILITY | Alamar Biosciences Laboratory, Inc. | 1994-12-15 | 267 | 0 |
| K930478 | READAR | Alamar Biosciences, Inc. | 1993-10-22 | 266 | 0 |
| K921977 | SYNERGY SCREEN TEST, MODIFICATION | Baxter Healthcare Corp | 1993-10-12 | 539 | 0 |
| K925951 | READAR | Alamar Biosciences Laboratory, Inc. | 1993-08-31 | 280 | 0 |
| K925859 | READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS | Alamar Biosciences, Inc. | 1993-07-08 | 233 | 0 |
| K922482 | MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL | Baxter Diagnostics, Inc. | 1993-03-12 | 289 | 0 |
| K911419 | SENSITITRE ARIS MODULE | Sensititre , Ltd. | 1992-07-01 | 457 | 0 |
| K911400 | WALKAWAY TM 40 | Baxter Healthcare Corp | 1991-11-19 | 235 | 1 |
| K900821 | AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-03-15 | 22 | 0 |
| K896447 | AUTOSCEPTOR | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-01-02 | 54 | 0 |
| K883907 | SCEPTORPETTE SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-27 | 42 | 0 |
| K865062 | ALADIN (TM) | Analytical Products, Inc. | 1987-03-25 | 91 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda