IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
FDA 510(k) clearance K060130 · decided 2006-02-13
Clearance details
- K-number
- K060130
- Device name
- IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-18
- Decision date
- 2006-02-13
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- CZP
- 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 |
|---|---|---|
| Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (K193525) | HORIBA ABX SAS | 2020-06-26 |
| ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 (K040435) | Roche Diagnostics Corp. | 2004-03-10 |
| N LATEX IGA (K024038) | Dade Behring, Inc. | 2003-02-13 |
| WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD (K993927) | Wako Chemicals USA, Inc. | 2000-01-14 |
| IGA (K983359) | Abbott Laboratories | 1998-11-04 |
| QUANTEX IGA (K962200) | Instrumentation Laboratory CO | 1996-09-25 |
| IGA IMMUNOTURBIDIMETRIC & CALIBRATOR (K955794) | Randox Laboratories, Ltd. | 1996-04-05 |
| BOEHRINGER MANNHEIM IGA ASSAY (K955907) | Boehringer Mannheim Corp. | 1996-02-09 |
| N LATEX IGA (K952309) | Behring Diagnostics, Inc. | 1995-06-20 |
| IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (K931806) | The Binding Site, Ltd. | 1993-07-16 |
| IL TEST IMMUNOGLOBULIN A (K920014) | Instrumentation Laboratory CO | 1992-06-16 |
| TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 (K900422) | Helena Laboratories | 1990-02-27 |
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 |