Product code CEO
- Device name
- Phosphomolybdate (Colorimetric), Inorganic Phosphorus
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1580
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | Seppim S.A.S. | 2011-05-06 |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 |
| K041643 | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT | Beckman Coulter, Inc. | 2004-08-18 |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | Elan Diagnostics | 2003-03-07 |
| K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | Abaxis, Inc. | 2002-09-05 |
| K013095 | WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 | Wiener Laboratories Saic | 2001-11-16 |
| K003912 | PHOSPHORUS REAGENT | Jas Diagnostics, Inc. | 2001-02-21 |
| K003012 | RAICHEM PHOSPORUS REAGENT | Hemagen Diagnostics, Inc. | 2000-10-25 |
| K991867 | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-08-02 |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Boehringer Mannheim Corp. | 1998-12-01 |
| K981769 | HICHEM PHOSPHORUS REAGENT KIT | Elan Pharma, Inc. | 1998-06-29 |
| K981610 | CARESIDE ANALYZER | Careside, Inc. | 1998-06-25 |
| K981759 | PHOS | Abbott Laboratories | 1998-06-16 |
| K981118 | PHOS | Abbott Laboratories | 1998-06-12 |
| K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 | Diagnostic Chemicals , Ltd. | 1998-01-30 |
| K974605 | RANDOX INORGANIC PHOSPHOROUS | Randox Laboratories, Ltd. | 1998-01-09 |
| K971363 | SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT | Carolina Liquid Chemistries Corp. | 1997-04-21 |
| K955937 | INORGANIC PHOSPHORUS REAGENT | Derma Media Lab., Inc. | 1996-03-12 |
| K944768 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus America, Inc. | 1995-03-24 |
| K942960 | PHOSPHATE QVET | Prisma Systems | 1994-12-09 |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | Emd Chemicals, Inc. | 1994-12-07 |
| K945368 | PHOSPHORUS TEST (PHOS) | Emd Chemicals, Inc. | 1994-12-02 |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Em Diagnostic Systems, Inc. | 1993-12-17 |
| K931835 | OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT | Olympus Corp. | 1993-09-08 |
| K932729 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) | Eastman Kodak Company | 1993-08-03 |
| K931361 | IL TEST PHOSPHORUS | Instrumentation Laboratory CO | 1993-05-11 |
| K925057 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus Corp. | 1992-11-19 |
| K924470 | TWO PART INORGANIC PHOSPHORUS TEST | Em Diagnostic Systems, Inc. | 1992-10-14 |
| K923764 | SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-22 |
| K923564 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus Corp. | 1992-08-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740155643 | Alinity | ABBOTT IRELAND | 2024-03-11 |
| 00380740155650 | Alinity | ABBOTT IRELAND | 2024-03-11 |
| 00380740155629 | ARCHITECT | ABBOTT IRELAND | 2024-02-26 |
| 00380740155636 | ARCHITECT | ABBOTT IRELAND | 2024-02-26 |
| 00850053916120 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-12 |
| 10673486001976 | Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC Matrix | TECO DIAGNOSTICS | 2023-11-13 |
| 10673486001945 | Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method) | TECO DIAGNOSTICS | 2023-11-10 |
| 10673486001969 | Teco Diagnostics Inorganic Phosphorus Reagent Set (UV Method) | TECO DIAGNOSTICS | 2023-11-10 |
| 06971674865117 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865100 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865124 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865087 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865070 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865131 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865056 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865148 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865155 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-22 |
| 06971674865094 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674865063 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674865049 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 06971674865032 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-21 |
| 05055273204865 | INORGANIC PHOSPHOROUS (PHOS) | RANDOX LABORATORIES LIMITED | 2022-10-05 |
| 00817302024197 | CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024272 | CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT CC218 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024432 | CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT DT218 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024579 | CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT ST218 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024098 | CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT AU-218 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-07-06 |
| 04015630918973 | Phosphate (Inorganic) ver.2 | Roche Diagnostics GmbH | 2021-05-27 |
| EABA40000371 | Piccolo MetLac 12 Panel | ABAXIS, INC. | 2016-09-23 |
| 03610230005194 | ABX PENTRA PHOSPHORUS CP | HORIBA ABX SAS | 2016-08-23 |