FDA.reportPublic FDA data

510(k) K030991

Device
C. DIFF CHEK - 30
Applicant
Techlab, Inc.
510(k) number
K030991
Product code
LLH
Decision
Substantially Equivalent (SESE)
Decision date
2003-07-11
Date received
2003-03-28
Regulation
866.2660
Classification name
Reagents, Clostridium Difficile Toxin
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
DAVID M LYERLY
Address
1861 Pratt Dr., Suite 1030 Blacksburg VA US 24060 24060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.2021-07-08
K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme Corporation2010-12-21
K091109XPERT C. DIFFICILECepheid2009-07-09
K090239PROGASTRO CD ASSAYProdesse, Inc.2009-04-16
K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.2009-03-26
K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)2008-12-19
K080931VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAYbioMerieux, Inc.2008-06-11
K072138VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118bioMerieux, Inc.2007-12-21
K050891TOX A/B QUICK CHEKTechlab, Inc.2005-07-25
K041951XPECT CLOSTRIDIUM DIFFICILE TOXIN A/BRemel, Inc.2004-11-15
K041003IMMUNOCARD TOXINS A & B, MODEL 712050Meridian Bioscience, Inc.2004-08-20
K032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96Ivd Research, Inc.2004-05-27
K033479PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAYRemel, Inc.2004-02-26
K030992C. DIFF CHEK - 60Techlab, Inc.2003-07-11
K030404C. DIFFICILE TOX A/B IITechlab, Inc.2003-04-24