ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
FDA 510(k) clearance K012208 · decided 2001-09-07
Clearance details
- K-number
- K012208
- Device name
- ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-16
- Decision date
- 2001-09-07
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- DDC
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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| ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (K971835) | Monobind | 1997-07-03 |
| SERODIA ATG (K953066) | Fujirebio America, Inc. | 1995-08-14 |
| AUTOSTAT II ANTI-THYROGLOBULIN (K943625) | Cogent Diagnotics , Ltd. | 1994-12-22 |
| THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY (K936010) | Biomerica, Inc. | 1994-07-18 |
| QUANTA LITE(TM) THYROID T ELISA (K930486) | Inova Diagnostics, Inc. | 1993-03-15 |
| SERA-TEK THYROGLOBULIN ANTIBODY TEST (K865020) | Miles Laboratories, Inc. | 1987-02-02 |
| THYMUNE-M (K780873) | Burroughs Wellcome Co. | 1978-06-14 |
| THYMUNE-T (K780874) | Burroughs Wellcome Co. | 1978-06-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890 recall (Z-0417-2007) | Beckman Coulter Inc | 2007-02-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |