Product code LRG— Microbiology
MICROSCAN MICROSTREP PLUS PANEL
- Classification name
- Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Total cleared
- 45
- First cleared
- Most recent
Market context for product code LRG
FDA has cleared devices under product code LRG between 1987 and 2019, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2019
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 1998
- 1994
- 1993
- 1992
- 1991
- 1990
- 1988
Top applicants under product code LRG
Recent clearances under product code LRG
- K191914 — Thermo Scientific Sensititre ARIS HiQ System
- K191918 — Thermo Scientific Sensititre ARIS HiQ System
- K110583 — SENSITITRE OPTIREAD
- K103532 — AUTOREADER 2
- K111677 — MICROSCAN(R) MICROSTREP PLUS(R)
- K111205 — MICROSCAN (R) MICROSTREP PLUS (R) PANELS
- K101425 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
- K081013 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
- K071316 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
- K063299 — MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
- K063102 — MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
- K063099 — MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)
- K063101 — MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML
- K063065 — MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)
- K062375 — MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)
- K063053 — MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)
- K063064 — MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
- K062923 — MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
- K062927 — MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
- K062585 — MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
- K062596 — MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
- K062290 — MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)
- K062293 — MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)
- K061872 — MICROSCAN MICROSTREP PLUS PANEL
- K062179 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)
- K062276 — MICROSCAN MICROSTREP PLUS PANEL
- K053243 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
- K050043 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
- K050585 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
- K043545 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
- K041150 — MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
- K033948 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
- K981199 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
- K941425 — ALAMAR ANTIBIOTIC SUSCEPTIBILITY
- K930478 — READAR
- K921977 — SYNERGY SCREEN TEST, MODIFICATION
- K925951 — READAR
- K925859 — READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS
- K922482 — MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL
- K911419 — SENSITITRE ARIS MODULE
- K911400 — WALKAWAY TM 40
- K900821 — AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
- K896447 — AUTOSCEPTOR
- K883907 — SCEPTORPETTE SYSTEM
- K865062 — ALADIN (TM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.