FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
K Number: K030528
·
Decision Jun 17, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
66
Applicant Total
1
Review Days
118
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
- ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
- K Number
- K030528
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Data
- Date Received
- February 19, 2003
- Decision Date
- June 17, 2003
- Product Code
- JIY
- 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 |
|---|---|---|---|
| JIY | Photometric Method, Iron (Non-Heme) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIY), ordered by most recent decision date.
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SENTINEL IRON LIQUID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITALAB IRON REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
FDA 510(k)
FDA Class 1
·Clinical Chemistry