Inorganic Phosphorus Procedure
FDA 510(k) K861661 · Data Medical Associates, Inc.
510(k) numberK861661
Submission
- Device name
- Inorganic Phosphorus Procedure
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- April 30, 1986
- Decision date
- July 1, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K993098 | Hdl-C/Ldl-C Calibrator, Model 1913-003JIX · Traditional | 10/08/1999SE |
| K971113 | Dma Triglycerides ProceduresCDT · Traditional | 05/29/1997SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | 07/01/1996SE |
| K955796 | Iron Calibrator & Calibration Verification SetJJX · Traditional | 02/29/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | 08/23/1995SE |
| K946354 | Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional | 05/08/1995SE |
| K946355 | Dma Albumin ProcedureCIX · Traditional | 03/01/1995SE |
Questions and answers
When was Inorganic Phosphorus Procedure cleared by the FDA?
Inorganic Phosphorus Procedure (K861661) received a 510(k) decision of Substantially Equivalent on July 1, 1986, 62 days after the submission was received.
What is the product code of K861661?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.