Atac Pak Phosphorus Reagent
FDA 510(k) K030015 · Elan Diagnostics
510(k) numberK030015
Submission
- Device name
- Atac Pak Phosphorus Reagent
- Applicant
- Elan Diagnostics
Brea, CA, US - Received
- January 2, 2003
- Decision date
- March 7, 2003
- 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 |
| K041643 | Synchron Systems Phosphorus (PHS) ReagentCEO · Traditional | Beckman Coulter, Inc. | 08/18/2004SE |
| 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 |
More from Elan Pharma, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030003 | Atac Direct Bilirubin Reagent and CalibratorCIG · Traditional | 09/29/2003SE |
| K030014 | Atac Total Bilirubin ReagentCIG · Traditional | 09/26/2003SE |
| K030621 | Atac CalibratorJIX · Traditional | 03/19/2003SE |
| K023105 | Atac Calcium Reagent and Atac CalibratorCIC · Traditional | 03/13/2003SE |
| K030010 | Atac Pak Magnesium ReagentJGJ · Traditional | 03/10/2003SE |
| K030006 | Atac Pak Albumin ReagentCIX · Traditional | 03/07/2003SE |
| K023407 | Atac Pak Creatinine Reagent and Atac CalibratorCGX · Traditional | 02/14/2003SE |
| K021385 | Atac Pak Bun ReagentCDQ · Traditional | 07/12/2002SE |
| K020575 | Atac Direct LDL Reagent and Atac Direct LDL Calibrator KitsMRR · Traditional | 04/12/2002SE |
| K002285 | Atac Pak Alp Reagent KitCJE · Traditional | 09/26/2000SE |
Questions and answers
When was Atac Pak Phosphorus Reagent cleared by the FDA?
Atac Pak Phosphorus Reagent (K030015) received a 510(k) decision of Substantially Equivalent on March 7, 2003, 64 days after the submission was received.
What is the product code of K030015?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.