Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

56 results for "Trek Diagnostic Systems, Inc."
1–24 of 56
Search insights Median review: 60d Cleared: 100% Top manufacturer: Trek Diagnostic Systems, Inc. Lead specialty: Microbiology
Cleared Feb 17, 2010
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 04, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
K090968 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 59d
Cleared Mar 24, 2009
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 109d
Cleared Mar 06, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K081063 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 326d
Cleared Oct 24, 2008
SENSITITRE VIZION
K081520 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Mar 20, 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Mar 13, 2008
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 85d
Cleared Jan 22, 2008
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K073424 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 48d
Cleared Dec 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY...
K062841 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 89d
Cleared Nov 09, 2006
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062839 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 49d
Cleared Nov 01, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062816 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 42d
Cleared Oct 26, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062783 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062722 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Sep 11, 2006
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062022 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 56d
Cleared Aug 31, 2006
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K062190 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 31d
Cleared May 16, 2006
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
K060783 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Jan 20, 2006
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K053243 · LRG
Trek Diagnostic Systems, Inc.
Microbiology · 60d
Cleared Jan 19, 2006
VERSATREK MYCO PZA KIT
K052323 · MJA
Trek Diagnostic Systems, Inc.
Microbiology · 147d
Cleared Sep 21, 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Apr 26, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 25d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Feb 03, 2004
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K033522 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 88d
Cleared Aug 29, 2003
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K032382 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 28d
Cleared Aug 22, 2003
VERSATREK
K032306 · MDB
Trek Diagnostic Systems, Inc.
Microbiology · 28d