Inorganic Phosphorous Reagent
FDA 510(k) K760990 · Worthington Biochemical Corp.
510(k) numberK760990
Submission
- Device name
- Inorganic Phosphorous Reagent
- Applicant
- Worthington Biochemical Corp.
Mchenry, IL, US - Received
- November 5, 1976
- Decision date
- November 16, 1976
- 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 |
|---|---|---|
| K780389 | HDL Reagent Set for LipoproteinsCHH · Traditional | 04/19/1978SE |
| K780096 | LDH Isoenzyme Control SerumJJY · Traditional | 03/03/1978SE |
| K772356 | LDH Isoenzyme Column Reagent SetCEX · Traditional | 01/24/1978SE |
| K772025 | Uric Acid Std. for Quant. Uric AcidJIS · Traditional | 11/11/1977SE |
| K771143 | Inorganic Phosphorus StandardsJIT · Traditional | 07/11/1977SE |
| K771001 | Statzyme GlucoseCGA · Traditional | 07/11/1977SE |
| K770831 | Statzyme Uric Acid ReagentCDO · Traditional | 07/11/1977SE |
| K770470 | Worthington BunCDW · Traditional | 06/02/1977SE |
| K770277 | Cholesterol StandardsJIT · Traditional | 03/01/1977SE |
| K761263 | Cholesterol Automated ReagentCHH · Traditional | 12/29/1976SE |
Questions and answers
When was Inorganic Phosphorous Reagent cleared by the FDA?
Inorganic Phosphorous Reagent (K760990) received a 510(k) decision of Substantially Equivalent on November 16, 1976, 11 days after the submission was received.
What is the product code of K760990?
The FDA product code is CEO – Phosphomolybdate (Colorimetric), Inorganic Phosphorus, a Class I (low risk) device regulated under 21 CFR 862.1580.