Albumin BCP
FDA 510(k) K193001 · SENTINEL CH. SpA
510(k) numberK193001
Submission
- Device name
- Albumin BCP
- Applicant
- SENTINEL CH. SpA
Milano, IT - Received
- October 28, 2019
- Decision date
- December 19, 2019
- 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 |
|---|---|---|---|
| K203530 | Albumin BCP2CJW · Traditional | Abbott Ireland Diagnostics Division | 03/18/2022SE |
| 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 |
|---|---|---|
| K242585 | Cystatin CNDY · Traditional | 05/16/2025SE |
| K211058 | Lp(a) UltraDFC · Traditional | 12/22/2022SE |
| K192118 | CRP VarioDCK · Special | 11/08/2019SE |
| K173833 | CRP VarioNQD · Traditional | 09/27/2018SE |
| K141728 | Ace CalibratorJIT · Abbreviated | 07/28/2014SE |
| K102706 | CKMB Udr AssayJHS · Traditional | 08/19/2011SE |
| K083602 | Kappa Light ChainsDFH · Traditional | 09/03/2009SE |
| K083601 | Lambda Light ChainsDEH · Traditional | 06/22/2009SE |
| K081533 | Sentinel Plasmaproteins Cal 3XJIX · Traditional | 06/25/2008SE |
| K073634 | Multigent Creatinine (Enzymatic) AssayJFY · Traditional | 06/19/2008SE |
Questions and answers
When was Albumin BCP cleared by the FDA?
Albumin BCP (K193001) received a 510(k) decision of Substantially Equivalent on December 19, 2019, 52 days after the submission was received.
What is the product code of K193001?
The FDA product code is CJW – Bromcresol Purple Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.