Inorganic Phosphorus Reagent
FDA 510(k) K955937 · Derma Media Lab., Inc.
510(k) numberK955937
Submission
- Device name
- Inorganic Phosphorus Reagent
- Applicant
- Derma Media Lab., Inc.
Santa Fe Springs, CA, US - Received
- December 21, 1995
- Decision date
- March 12, 1996
- 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 |
| 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 |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K971309 | UreaCDQ · Traditional | 08/01/1997SE |
| K970664 | Glucose ReagentCFR · Traditional | 08/01/1997SE |
| K971072 | Cholesterol ReagentCHH · Traditional | 06/20/1997SE |
| K971005 | TriglyceridesJGY · Traditional | 04/21/1997SE |
| K970867 | Uric Acid ReagentKNK · Traditional | 04/21/1997SE |
| K964915 | MagnesiumJGJ · Traditional | 03/26/1997SE |
| K964913 | Iron ReagentJIY · Traditional | 02/20/1997SE |
| K965134 | Alt/SgptCKA · Traditional | 02/18/1997SE |
| K964914 | Alkaline PhosphataseCJE · Traditional | 02/04/1997SE |
| K965126 | Ast/SgotCIT · Traditional | 01/17/1997SE |
Questions and answers
When was Inorganic Phosphorus Reagent cleared by the FDA?
Inorganic Phosphorus Reagent (K955937) received a 510(k) decision of Substantially Equivalent on March 12, 1996, 82 days after the submission was received.
What is the product code of K955937?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.