Albumin BCP2
FDA 510(k) K203530 · Abbott Ireland Diagnostics Division
510(k) numberK203530
Submission
- Device name
- Albumin BCP2
- Applicant
- Abbott Ireland Diagnostics Division
Longford, IE - Received
- December 2, 2020
- Decision date
- March 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJW – Bromcresol Purple Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193001 | Albumin BCPCJW · Traditional | SENTINEL CH. SpA | 12/19/2019SE |
| K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP CalibratorCJW · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/16/2013SE |
| K021636 | Albumin ReagentCJW · Traditional | Intersect Systems, Inc. | 07/17/2002SE |
| K000483 | Randox AlbuminCJW · Traditional | Randox Laboratories, Ltd. | 03/31/2000SE |
| K990978 | Albumin BCG, Model Al 103-01CJW · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K981814 | AlbpCJW · Traditional | Abbott Laboratories | 07/22/1998SE |
| K981457 | AlbpCJW · Traditional | Abbott Mfg., Inc. | 05/27/1998SE |
| K913025 | Abbott Quickstart Albumin BCP (ALBP)#5A16CJW · Traditional | Em Diagnostic Systems, Inc. | 10/09/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | Biochemical Trade, Inc. | 02/26/1991SE |
| K863226 | Albumin (BCP)CJW · Traditional | Sigma Diagnostics, Inc. | 09/17/1986SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K223317 | Alkaline Phosphatase2CJE · Traditional | 07/21/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | 12/29/2022SE |
| K203597 | Cholesterol2CHH · Traditional | 06/30/2022SE |
| K203771 | Urea Nitrogen2CDQ · Traditional | 05/31/2022SE |
| K210633 | Amylase2JFJ · Traditional | 05/26/2022SE |
| K210452 | Creatinine2CGX · Traditional | 03/22/2022SE |
| K203248 | Albumin BCG2CIX · Traditional | 11/23/2021SE |
Questions and answers
When was Albumin BCP2 cleared by the FDA?
Albumin BCP2 (K203530) received a 510(k) decision of Substantially Equivalent on March 18, 2022, 471 days after the submission was received.
What is the product code of K203530?
The FDA product code is CJW – Bromcresol Purple Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.