FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT TDX/TDXFLX TT4
K Number: K925109
·
Decision Jan 4, 1993
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
883
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ABBOTT TDX/TDXFLX TT4
- K Number
- K925109
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- October 9, 1992
- Decision Date
- January 4, 1993
- Product Code
- CDX
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDX), ordered by most recent decision date.
ELECSYS T4 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVE THYROXINE RIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DELFIA NEONATAL THYROXINE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXSYM(TM) TOTAL T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |