ClearanceBrief
Company ยท US

Thera Test Laboratories, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2009. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
2recalls that name a 510(k)

Product codes

CodeDeviceRecords
QKOReagent, Coronavirus Serological2
DHRSystem, Test, Rheumatoid Factor1
MIDSystem, Test, Anticardiolipin Immunological1
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 9, 2009K092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
Thera-Test Laboratories, Inc.
MSV

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 5, 2020Thera Test Laboratories, Inc.
EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
Terminated		 QKONone listed
Jul 30, 2020Thera Test Laboratories, Inc.
EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Terminated		 QKONone listed
May 14, 2012Thera Test Laboratories, Inc.
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTe
Terminated		 DHRK941398
May 4, 2006Thera Test Laboratories, Inc.
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard,
Terminated		 MIDK060176
Get alerts for these product codes