Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator
FDA 510(k) K132664 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK132664
Submission
- Device name
- Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- August 27, 2013
- Decision date
- October 16, 2013
- 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 |
| K193001 | Albumin BCPCJW · Traditional | SENTINEL CH. SpA | 12/19/2019SE |
| 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 |
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Questions and answers
When was Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator cleared by the FDA?
Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP Calibrator (K132664) received a 510(k) decision of Substantially Equivalent on October 16, 2013, 50 days after the submission was received.
What is the product code of K132664?
The FDA product code is CJW – Bromcresol Purple Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.