Phosphorus Reagent
FDA 510(k) K003912 · Jas Diagnostics, Inc.
510(k) numberK003912
Submission
- Device name
- Phosphorus Reagent
- Applicant
- Jas Diagnostics, Inc.
Miami, FL, US - Received
- December 19, 2000
- Decision date
- February 21, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K041643 | Synchron Systems Phosphorus (PHS) ReagentCEO · Traditional | Beckman Coulter, Inc. | 08/18/2004SE |
| 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 |
| 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 |
More from Elan Pharma, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K130915 | XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJJE · Traditional | 05/15/2014SE |
| K080623 | Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model NaCHH · Traditional | 11/17/2008SE |
| K080618 | Direct HBA1C, Fructosamine, Glucose Oxidase LiquidLCP · Traditional | 05/23/2008SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | 09/30/2002SE |
| K021671 | Jas HDL Cholesterol (Automated) ReagentLBS · Traditional | 07/19/2002SE |
| K020454 | Chemistry CalibratorJIT · Traditional | 04/08/2002SE |
| K020282 | Jas Amylase Liquid ReagentJFJ · Traditional | 02/28/2002SE |
| K013912 | Creatine Kinase (Ck-Nac)CGS · Traditional | 01/18/2002SE |
| K013698 | Ast (Sgot)CIT · Traditional | 12/21/2001SE |
| K012332 | Jas Carbon Dioxide Liquid ReagentKHS · Traditional | 09/06/2001SE |
Questions and answers
When was Phosphorus Reagent cleared by the FDA?
Phosphorus Reagent (K003912) received a 510(k) decision of Substantially Equivalent on February 21, 2001, 64 days after the submission was received.
What is the product code of K003912?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.