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."
25–48 of 56
Search insights Median review: 60d Cleared: 100% Top manufacturer: Trek Diagnostic Systems, Inc. Lead specialty: Microbiology
Cleared Jul 16, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
K031545 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 61d
Cleared Mar 17, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 77d
Cleared Mar 06, 2003
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K024353 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Oct 08, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 60d
Cleared Sep 25, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 47d
Cleared Sep 25, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021997 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 98d
Cleared Jun 20, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021627 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared May 15, 2002
CEFOTAXIME
K020859 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 58d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 09, 2002
GATIFLOXIN
K020762 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 90d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Dec 21, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
K013925 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 37d
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 44d
Cleared Nov 26, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013075 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Nov 20, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 40d
Cleared Nov 07, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 43d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Oct 09, 2001
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
K991810 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 866d
Cleared Sep 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012565 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Aug 29, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012151 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 65d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d