IGA
FDA 510(k) clearance K983359 · decided 1998-11-04
Clearance details
- K-number
- K983359
- Device name
- IGA
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-09-24
- Decision date
- 1998-11-04
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- CZP
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Abbott Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130) | Beckman Coulter, Inc. | 2006-02-13 |
| 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 |
| 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 |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |