FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Creatinine2
K Number: K210452
·
Decision Mar 22, 2022
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
158
Applicant Total
8
Review Days
399
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
- Creatinine2
- K Number
- K210452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Ireland Diagnostics Division
- Date Received
- February 16, 2021
- Decision Date
- March 22, 2022
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CGX), ordered by most recent decision date.
Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tru Kidney Health Test Panel; Tru Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica® CH Creatinine_3 (Crea3)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nova Allegro UACR Assay, Nova Allegro Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Abbott Ireland Diagnostics Division
| K Number | Device Name | ||
|---|---|---|---|
| K223317 | Alkaline Phosphatase2 | Jul 21, 2023 | Substantially Equivalent |
| K223324 | Total Bilirubin2 | Dec 29, 2022 | Substantially Equivalent |
| K203597 | Cholesterol2 | Jun 30, 2022 | Substantially Equivalent |
| K203771 | Urea Nitrogen2 | May 31, 2022 | Substantially Equivalent |
| K210633 | Amylase2 | May 26, 2022 | Substantially Equivalent |
| K203530 | Albumin BCP2 | Mar 18, 2022 | Substantially Equivalent |
| K203248 | Albumin BCG2 | Nov 23, 2021 | Substantially Equivalent |