FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Albumin BCP2
K Number: K203530
·
Decision Mar 18, 2022
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
17
Applicant Total
8
Review Days
471
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Basic Information
- Device Name
- Albumin BCP2
- K Number
- K203530
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Ireland Diagnostics Division
- Date Received
- December 2, 2020
- Decision Date
- March 18, 2022
- Product Code
- CJW
- 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 |
|---|---|---|---|
| CJW | Bromcresol Purple Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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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 |
| K210452 | Creatinine2 | Mar 22, 2022 | Substantially Equivalent |
| K203248 | Albumin BCG2 | Nov 23, 2021 | Substantially Equivalent |