FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IGA
K Number: K983359
·
Decision Nov 4, 1998
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
53
Applicant Total
857
Review Days
41
Basic Information
- Device Name
- IGA
- K Number
- K983359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT LABORATORIES
- Date Received
- September 24, 1998
- Decision Date
- November 4, 1998
- Product Code
- CZP
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CZP | Iga, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CZP), ordered by most recent decision date.
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
FDA 510(k)
FDA Class 2
·Immunology
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
FDA 510(k)
FDA Class 2
·Immunology
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
FDA 510(k)
FDA Class 2
·Immunology
N LATEX IGA
FDA 510(k)
FDA Class 2
·Immunology
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
FDA 510(k)
FDA Class 2
·Immunology
QUANTEX IGA
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by ABBOTT LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Oct 23, 2017 | Substantially Equivalent |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | Aug 12, 2016 | Substantially Equivalent |
| K152442 | Freestyle Freedom Blood Glucose Monitoring Sytem | Dec 17, 2015 | Substantially Equivalent |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Jul 10, 2015 | Substantially Equivalent |
| K150332 | FreeStyle Lite Blood Glucose Monitoring System | Jun 5, 2015 | Substantially Equivalent |
| K140654 | Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls | May 22, 2015 | Substantially Equivalent |
| K150510 | Total Bilirubin | Apr 2, 2015 | Substantially Equivalent |
| K130255 | HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS | Feb 28, 2014 | Substantially Equivalent |
| K123089 | FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 | Apr 5, 2013 | Substantially Equivalent |