Thymune-T

FDA 510(k) K780874 · Burroughs Wellcome Co.

Substantially Equivalent

510(k) numberK780874

Submission

Device name
Thymune-T
Applicant
Burroughs Wellcome Co.
Mchenry, IL, US
Received
May 30, 1978
Decision date
June 14, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DDC – Thyroglobulin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5870
Specialty
Immunology

Other 510(k)s with product code DDC

510(k)DeviceApplicantDecision
K023592Seraquest Anti-ThyroglobulinDDC · Traditional Quest Intl., Inc.01/06/2003SE
K012208Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models…DDC · Traditional Beckman Coulter, Inc.09/07/2001SE
K000363Modification to Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Special Zeus Scientific, Inc.02/18/2000SE
K991610Zeus Scientific Inc., Tpo Igg Elisa Test System.DDC · Traditional Zeus Scientific, Inc.06/25/1999SE
K991179Zeus Scientific, Inc., Thyroglobulin Igg Elisa Test SystemDDC · Traditional Zeus Scientific, Inc.06/17/1999SE
K971835Anti-Thyroglobulin (TG) Microplate ElisaDDC · Traditional Monobind07/03/1997SE
K953066Serodia AtgDDC · Traditional Fujirebio America, Inc.08/14/1995SE
K943625Autostat II Anti-ThyroglobulinDDC · Traditional Cogent Diagnotics , Ltd.12/22/1994SE
K936010Thyroglobulin Autoantibody Enzyme ImmunoassayDDC · Traditional Biomerica, Inc.07/18/1994SE
K930486Quanta Lite(Tm) Thyroid T ElisaDDC · Traditional Inova Diagnostics, Inc.03/15/1993SE

More from Inova Diagnostics, Inc.

510(k)DeviceDecision
K820069Wellcogen Group BGTZ · Traditional 02/18/1982SE
K813508Sac-CelKTS · Traditional 12/29/1981SE
K810215Dac-Cel HCGJHI · Traditional 04/17/1981SE
K810214Dac-Cel DiagnatalJHI · Traditional 03/06/1981SE
K810213Dac-Cel TSHJLW · Traditional 02/10/1981SE
K810212Dac-Cel T3 UptakeKHQ · Traditional 02/10/1981SE
K791232Dac-Cel T3CDP · Traditional 09/04/1979SE
K791231Dac-Cel T4CDX · Traditional 09/04/1979SE
K781607Strep-TexGTZ · Traditional 10/17/1978SE
K780873Thymune-MDDC · Traditional 06/14/1978SE

Questions and answers

When was Thymune-T cleared by the FDA?

Thymune-T (K780874) received a 510(k) decision of Substantially Equivalent on June 14, 1978, 15 days after the submission was received.

What is the product code of K780874?

The FDA product code is DDC – Thyroglobulin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5870.