Access Ferritin
FDA 510(k) clearance K234052 · decided 2024-03-20
Clearance details
- K-number
- K234052
- Device name
- Access Ferritin
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-21
- Decision date
- 2024-03-20
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JMG
- Device class
- 2
- Regulation number
- 866.5340
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chaska, MN, 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 |
|---|---|---|
| FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (K052082) | Beckman Coulter, Inc. | 2005-08-19 |
| TINA-QUANT FERRITIN ASSAY (K964282) | Boehringer Mannheim Corp. | 1997-07-30 |
| ELECSYS FERRITIN (K971833) | Boehringer Mannheim Corp. | 1997-06-02 |
| FERR FLEX REAGENT CARTRIDGE (K963498) | Dade Chemistry Systems, Inc. | 1997-01-24 |
| ACE(TM) CEDIA(R) FERRITIN ASSAY (K950393) | Schiapparelli Biosystems, Inc. | 1995-05-16 |
| ACCESS FERRITIN ASSAY (K926221) | Bio-Rad Laboratories, Inc. | 1993-01-13 |
| IMMULITE FERRITIN (K925848) | Diagnostic Products Corp. | 1993-01-13 |
| COBAS CORE FERRITIN EIA (K920829) | Roche Diagnostic Systems, Inc. | 1992-06-19 |
| CEDIA FERRITIN ASSAY (K920318) | Microgenics Corp. | 1992-06-04 |
| MILENIA (TM) FERRITIN (K902997) | Diagnostic Products Corp. | 1990-08-02 |
| RIA-GNOST FERRITIN (K890697) | Cambridge Medical Technology | 1989-03-16 |
| CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. (K881138) | Baxter Healthcare Corp | 1988-04-21 |
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 |