BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
FDA 510(k) clearance K130122 · decided 2014-01-07
Clearance details
- K-number
- K130122
- Device name
- BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-17
- Decision date
- 2014-01-07
- Days to decision
- 355 days
- Clearance type
- Traditional
- Product code
- CFN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (K233663) | Siemens Healthcare Diagnostics Products GmbH | 2023-12-13 |
| Immunoglobulin G (IgG) (K221114) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-08-02 |
| Human IgA liquid reagent kit for Use on SPAPlus (K192116) | The Binding Site Group , Ltd. | 2019-09-04 |
| Optilite IgA Kit (K191985) | The Binding Site Group , Ltd. | 2019-08-19 |
| Optilite IgM Kit (K191635) | The Binding Site Group , Ltd. | 2019-07-15 |
| Human IgM Kit for use on SPAPlus (K191465) | The Binding Site Group , Ltd. | 2019-06-27 |
| Optilite IgM CSF Kit (K190686) | The Binding Site Group , Ltd. | 2019-05-28 |
| Optilite IgA CSF Kit (K183151) | The Binding Site Group , Ltd. | 2019-01-23 |
| DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208) | Beckman Coulter, Inc. | 2017-01-09 |
| Optilite IgG4 Kit (K150526) | The Binding Site Group , Ltd. | 2015-05-30 |
| The Optilite IgG3 kit (K142735) | The Binding Site Group , Ltd. | 2014-12-21 |
| HUMAN IGA CSF KIT FOR USE ON SPAPLUS (K120901) | The Binding Site Group , Ltd. | 2013-05-30 |
Recalls involving this device
No recalls on record reference this clearance.
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 |