510(k) K002905
- Device
- ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K002905
- Product code
- MSW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-10-19
- Date received
- 2000-09-18
- Regulation
- 866.6010
- Classification name
- System, Test, Thyroglobulin
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARA CALER
- Address
- 7330 Carroll Rd. P.O. Box 269006 San Diego CA US 92196 92196
FDA Registration Numbers#
- 3015529350
- 2025560
- 8031673
- 2020726
- 9612316
- 2432235
- 9610126
- 2521625
- 2122870
- 3006198300
- 1036362
- 3002806944
- 1219913
Source Documents#
Other 510(k) Records For Product Code MSW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-28 |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | 2024-06-07 |
| K221890 | Elecsys Tg II | Roche Diagnostics | 2023-09-30 |
| K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | 2023-09-15 |
| K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2003-05-02 |
| K021057 | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | Brahms Diagnostica, LLC | 2002-09-17 |
| K002888 | NICHOLS ADVANTAGE THYROGLOB | Nichols Institute Diagnostics | 2000-10-20 |
| K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | Nichols Institute Diagnostics | 2000-05-09 |
| K991720 | KRONUS OPTIQUANT THYROGLOBULIN KIT | Unchanged | 1999-08-09 |
| K982466 | IMMULITE THYROGLOBULIN MODEL LKTY | Diagnostic Products Corp. | 1999-03-12 |
| K982468 | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY | Diagnostic Products Corp. | 1999-03-12 |
Legacy Summary#
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FDA Review#
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