Synchron Systems Phosphorus (PHS) Reagent
FDA 510(k) K041643 · Beckman Coulter, Inc.
510(k) numberK041643
Submission
- Device name
- Synchron Systems Phosphorus (PHS) Reagent
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- June 17, 2004
- Decision date
- August 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1580
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100263 | Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsCEO · Traditional | Seppim S.A.S. | 05/06/2011SE |
| K072141 | S40 Clinical Analyzer, S Test Ip, S Test UaCEO · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K030015 | Atac Pak Phosphorus ReagentCEO · Traditional | Elan Diagnostics | 03/07/2003SE |
| K022312 | Piccolo Phosphorus Test SystemCEO · Traditional | Abaxis, Inc. | 09/05/2002SE |
| K013095 | Wiener Lab.Fosfatemia UV, Models 1X100 ML Cat.N 1382321, 4X20 ML Cat.N 1009311CEO · Traditional | Wiener Laboratories Saic | 11/16/2001SE |
| K003912 | Phosphorus ReagentCEO · Traditional | Jas Diagnostics, Inc. | 02/21/2001SE |
| K003012 | Raichem Phosporus ReagentCEO · Special | Hemagen Diagnostics, Inc. | 10/25/2000SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | A.P. Total Care, Inc. | 08/02/1999SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | Boehringer Mannheim Corp. | 12/01/1998SE |
| K981769 | Hichem Phosphorus Reagent KitCEO · Traditional | Elan Pharma, Inc. | 06/29/1998SE |
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Questions and answers
When was Synchron Systems Phosphorus (PHS) Reagent cleared by the FDA?
Synchron Systems Phosphorus (PHS) Reagent (K041643) received a 510(k) decision of Substantially Equivalent on August 18, 2004, 62 days after the submission was received.
What is the product code of K041643?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.