Access Intrinsic Factor Ab
FDA 510(k) clearance K240800 · decided 2024-05-03
Clearance details
- K-number
- K240800
- Device name
- Access Intrinsic Factor Ab
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-25
- Decision date
- 2024-05-03
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- LIG
- Device class
- 2
- Regulation number
- 862.1810
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| IMMULISA INTRINSIC FACTOR ANTIBODY ELISA (K071346) | Immco Diagnostics, Inc. | 2007-09-24 |
| QUANTA LITE INTRINSIC FACTOR ELISA (K061841) | Inova Diagnostics, Inc. | 2006-12-22 |
| INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 (K033603) | Beckman Coulter, Inc. | 2003-12-19 |
| IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 (K993251) | Diagnostic Products Corp. | 1999-11-17 |
| ABBOTT ARCHITECT B12 (K984108) | Abbott Laboratories | 1999-02-03 |
| IMX B12 (K903218) | Abbott Laboratories | 1990-08-23 |
| 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY (K811927) | Corning Medical & Scientific | 1982-04-01 |
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 |