510(k) K061382
- Device
- ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K061382
- Product code
- JZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-07-06
- Date received
- 2006-05-18
- Regulation
- 866.5870
- Classification name
- System, Test, Thyroid Autoantibody
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VALYNDA L MACHEN
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 8043792
- 2025560
- 2242436
- 2432235
- 1421346
- 3005333358
- 3006198300
- 3002806944
- 3011989923
- 9680746
- 3002800697
- 3002809144
- 3039353646
- 3007208259
- 2029372
- 9610126
- 2245285
- 8020888
- 1036362
- 2090110
- 1181121
- 8031673
- 2032839
- 3008344661
- 3033967997
- 3003834021
- 8023018
- 9610566
- 2122870
- 2915274
- 3005529799
- 9612316
- 3004973408
- 1528450
- 1219913
Source Documents#
Other 510(k) Records For Product Code JZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024-08-09 |
| K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | 2023-09-26 |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics | 2023-09-15 |
| K193313 | Elecsys Anti-TSHR | Roche Diagnostics | 2020-02-27 |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | Phadia AB | 2016-03-25 |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2016-03-03 |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | Diagnostic Hybrids, Inc. | 2010-05-18 |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | Theratest Laboratories, Inc. | 2009-09-03 |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | Diagnostic Hybrids, Inc. | 2009-05-21 |
| K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | Roche Diagnostics Corp. | 2008-07-28 |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-05-22 |
| K061794 | FIDIS TM THYRO, MODEL MX002 | Biomedical Diagnostics (Bmd) SA | 2006-11-21 |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | Fisher Diagnostics | 2006-07-18 |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | Fisher Diagnostics | 2006-05-10 |
Legacy Summary#
summary
FDA Review#
Decision Summary