Immulite Anti-Tg AB

FDA 510(k) K980206 · Diagnostic Products Corp.

Substantially Equivalent

510(k) numberK980206

Submission

Device name
Immulite Anti-Tg AB
Applicant
Diagnostic Products Corp.
Los Angeles, CA, US
Received
January 20, 1998
Decision date
May 1, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…JZO · Traditional Phadia AB03/25/2016SE
K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO · Traditional Siemens Healthcare Diagnostics, Inc.03/03/2016SE
K092229Thyretain TM Tsi Reporter BioassayJZO · Traditional Diagnostic Hybrids, Inc.05/18/2010SE
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More from Diagnostic Hybrids, Inc.

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K053533Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional 02/03/2006SE
K034055Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special 01/21/2004SE
K033234Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional 12/12/2003SE
K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special 10/10/2003SE
K023152Immulite 2000 Allergen-Specific IgeDHB · Abbreviated 12/17/2002SE
K023304Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional 12/09/2002SE
K022603Immulite 1000 Automated Immunoassay AnalyzerCEW · Special 08/21/2002SE

Questions and answers

When was Immulite Anti-Tg AB cleared by the FDA?

Immulite Anti-Tg AB (K980206) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 101 days after the submission was received.

What is the product code of K980206?

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