FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Alkaline Phosphatase2
K Number: K223317
·
Decision Jul 21, 2023
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
8
Review Days
266
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
- Alkaline Phosphatase2
- K Number
- K223317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Ireland Diagnostics Division
- Date Received
- October 28, 2022
- Decision Date
- July 21, 2023
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CJE), ordered by most recent decision date.
Tru Liver Health Test Panel
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alkaline Phosphatase
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Yumizen C1200 ALP, Yumizen C1200 Albumin
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALP IFCC Gen.2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Abbott Ireland Diagnostics Division
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K210452 | Creatinine2 | Mar 22, 2022 | Substantially Equivalent |
| K203530 | Albumin BCP2 | Mar 18, 2022 | Substantially Equivalent |
| K203248 | Albumin BCG2 | Nov 23, 2021 | Substantially Equivalent |