Inorganic Phosphorus Reagent Set
FDA 510(k) K880676 · Tech-Neal Scientific, Inc.
510(k) numberK880676
Submission
- Device name
- Inorganic Phosphorus Reagent Set
- Applicant
- Tech-Neal Scientific, Inc.
Chicago, IL, US - Received
- February 19, 1988
- Decision date
- March 24, 1988
- 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 |
|---|---|---|
| K882256 | Magnesium Reagent SetJGJ · Traditional | 08/08/1988SE |
| K882459 | Diazo, Colorimetric BilirubinCIG · Traditional | 08/02/1988SE |
| K881239 | Gamma Glutamyl Transferase Reagent SetJPZ · Traditional | 05/31/1988SE |
| K881241 | Total Bilirubin ReagentCIG · Traditional | 05/27/1988SE |
| K881240 | Chloride Reagent SetCHJ · Traditional | 04/28/1988SE |
| K881237 | Creatine Kinase (CK) Reagent SetJHX · Traditional | 04/28/1988SE |
| K880237 | CholesterolCHH · Traditional | 04/28/1988SE |
| K880277 | Uric Acid Reagent SetKNK · Traditional | 04/18/1988SE |
| K880845 | Calcium Reagent SetCIC · Traditional | 04/05/1988SE |
| K880844 | Albumin Reagent SetCIX · Traditional | 04/05/1988SE |
Questions and answers
When was Inorganic Phosphorus Reagent Set cleared by the FDA?
Inorganic Phosphorus Reagent Set (K880676) received a 510(k) decision of Substantially Equivalent on March 24, 1988, 34 days after the submission was received.
What is the product code of K880676?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.