Medica Iif-Anti-Thyroid Antibody Test

Q: What is the product code of K843343?

The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.

FDA 510(k) K843343 · Medical Diagnostics, Ca.

Substantially Equivalent

510(k) numberK843343

Submission

Device name: Medica Iif-Anti-Thyroid Antibody Test
Applicant: Medical Diagnostics, Ca.
Calsbad, CA, US
Received: August 27, 1984
Decision date: October 22, 1984
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: JZO – System, Test, Thyroid Autoantibody
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5870
Specialty: Immunology

Other 510(k)s with product code JZO

510(k)	Device	Applicant	Decision
K250250	ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional	Siemens Healthcare Diagnostics, Inc.	10/17/2025SE
K240469	Access TPO AntibodyJZO · Traditional	Beckman Coulter, Inc.	08/09/2024SE
K213517	Access Thyroglobulin Antibody IIJZO · Traditional	Beckman Coulter, Inc.	09/26/2023SE
K222610	Elecsys Anti-TgJZO · Traditional	Roche Diagnostics	09/15/2023SE
K193313	Elecsys Anti-TSHRJZO · Traditional	Roche Diagnostics	02/27/2020SE
K151799	EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…JZO · Traditional	Phadia AB	03/25/2016SE
K152061	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO · Traditional	Siemens Healthcare Diagnostics, Inc.	03/03/2016SE
K092229	Thyretain TM Tsi Reporter BioassayJZO · Traditional	Diagnostic Hybrids, Inc.	05/18/2010SE
K090760	Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional	Theratest Laboratories, Inc.	09/03/2009SE
K083391	Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional	Diagnostic Hybrids, Inc.	05/21/2009SE

More from Diagnostic Hybrids, Inc.

510(k)	Device	Decision
K853140	Mdi Quik Test Narcotics Drug ScreenDNK · Traditional	03/03/1986SE
K843900	Focuscope Universal SystemGDB · Traditional	12/06/1984SE
K831100	Medica Iif-Multiple Antibody Test KitDBM · Traditional	05/04/1983SE

Questions and answers

When was Medica Iif-Anti-Thyroid Antibody Test cleared by the FDA?

Medica Iif-Anti-Thyroid Antibody Test (K843343) received a 510(k) decision of Substantially Equivalent on October 22, 1984, 56 days after the submission was received.

What is the product code of K843343?

The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.