Immulite Thyroglobulin Model Lkty
FDA 510(k) K982466 · Diagnostic Products Corp.
510(k) numberK982466
Submission
- Device name
- Immulite Thyroglobulin Model Lkty
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- July 15, 1998
- Decision date
- March 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg)MSW · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/20/2025SE |
| K240927 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 06/28/2024SE |
| K241423 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 06/07/2024SE |
| K221890 | Elecsys Tg IIMSW · Traditional | Roche Diagnostics | 09/30/2023SE |
| K220972 | Access ThyroglobulinMSW · Traditional | Beckman Coulter, Inc. | 09/15/2023SE |
| K031269 | Access Thyroglobulin Reagents on the Access Immunoassay SystemsMSW · Special | Beckman Coulter, Inc. | 05/02/2003SE |
| K021057 | Brahms Diagnostica Dynotest Tg-PlusMSW · Traditional | Brahms Diagnostica, LLC | 09/17/2002SE |
| K002888 | Nichols Advantage ThyroglobMSW · Traditional | Nichols Institute Diagnostics | 10/20/2000SE |
| K002905 | Access Thyroglobulin Reagents on the Access AnalyzerMSW · Traditional | Beckman Coulter, Inc. | 10/19/2000SE |
| K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240MSW · Traditional | Nichols Institute Diagnostics | 05/09/2000SE |
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Questions and answers
When was Immulite Thyroglobulin Model Lkty cleared by the FDA?
Immulite Thyroglobulin Model Lkty (K982466) received a 510(k) decision of Substantially Equivalent on March 12, 1999, 240 days after the submission was received.
What is the product code of K982466?
The FDA product code is MSW – System, Test, Thyroglobulin, a Class II (moderate risk) device regulated under 21 CFR 866.6010.