Kronus Optiquant Thyroglobulin Kit

FDA 510(k) K991720 · Unchanged

Substantially Equivalent

510(k) numberK991720

Submission

Device name
Kronus Optiquant Thyroglobulin Kit
Applicant
Unchanged
San Clemente, CA, US
Received
May 20, 1999
Decision date
August 9, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MSW – System, Test, Thyroglobulin
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Specialty
Immunology

Other 510(k)s with product code MSW

510(k)DeviceApplicantDecision
K242981Atellica IM Thyroglobulin (Tg)MSW · Traditional Siemens Healthcare Diagnostics, Inc.06/20/2025SE
K240927Access ThyroglobulinMSW · Traditional Beckman Coulter, Inc.06/28/2024SE
K241423Access ThyroglobulinMSW · Traditional Beckman Coulter, Inc.06/07/2024SE
K221890Elecsys Tg IIMSW · Traditional Roche Diagnostics09/30/2023SE
K220972Access ThyroglobulinMSW · Traditional Beckman Coulter, Inc.09/15/2023SE
K031269Access Thyroglobulin Reagents on the Access Immunoassay SystemsMSW · Special Beckman Coulter, Inc.05/02/2003SE
K021057Brahms Diagnostica Dynotest Tg-PlusMSW · Traditional Brahms Diagnostica, LLC09/17/2002SE
K002888Nichols Advantage ThyroglobMSW · Traditional Nichols Institute Diagnostics10/20/2000SE
K002905Access Thyroglobulin Reagents on the Access AnalyzerMSW · Traditional Beckman Coulter, Inc.10/19/2000SE
K994140Nichols Chemiluminescence Thyroglobulin, Model 60-4240MSW · Traditional Nichols Institute Diagnostics05/09/2000SE

Questions and answers

When was Kronus Optiquant Thyroglobulin Kit cleared by the FDA?

Kronus Optiquant Thyroglobulin Kit (K991720) received a 510(k) decision of Substantially Equivalent on August 9, 1999, 81 days after the submission was received.

What is the product code of K991720?

The FDA product code is MSW – System, Test, Thyroglobulin, a Class II (moderate risk) device regulated under 21 CFR 866.6010.