Albumin Reagent
FDA 510(k) K021636 · Intersect Systems, Inc.
510(k) numberK021636
Submission
- Device name
- Albumin Reagent
- Applicant
- Intersect Systems, Inc.
Longview, WA, US - Received
- May 17, 2002
- Decision date
- July 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP CalibratorCJW · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/16/2013SE |
| 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 |
|---|---|---|
| K011972 | Direct Bilirubin ReagentCIG · Traditional | 08/27/2001SE |
| K011692 | Homogeneous Enzymic Homocysteine ReagentLPS · Traditional | 07/25/2001SE |
| K003892 | Total Bilirubin ReagentCIG · Traditional | 02/20/2001SE |
| K983937 | Dual Vial Creatinine ReagentCGX · Traditional | 01/06/1999SE |
| K974833 | Ck-Nac ReagentCGS · Traditional | 02/13/1998SE |
| K941807 | Intersect Systems' Non-Mercuric Chloride ReagentCHG · Traditional | 09/14/1994SE |
| K932888 | Intersect Systems Direct Amylase ReagentJFJ · Traditional | 01/31/1994SE |
| K934039 | Intersect Systems HDL Cholesterol Reagent SetLBR · Traditional | 11/16/1993SE |
| K932267 | Enzymatic CO2 Reagent, ModificationKHS · Traditional | 09/24/1993SE |
| K913225 | Urine/Csf Microprotein ReagentCEK · Traditional | 10/11/1991SE |
Questions and answers
When was Albumin Reagent cleared by the FDA?
Albumin Reagent (K021636) received a 510(k) decision of Substantially Equivalent on July 17, 2002, 61 days after the submission was received.
What is the product code of K021636?
The FDA product code is CJW – Bromcresol Purple Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.