CEO · Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Clinical Chemistry · 21 CFR 862.1580 · Class 1
Overview
| Product Code | CEO |
|---|---|
| Device Name | Phosphomolybdate (Colorimetric), Inorganic Phosphorus |
| Regulation | 21 CFR 862.1580 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 105)
Showing 20 most recent of 105 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | Seppim S.A.S. | May 6, 2011 | SESE |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | Alfa Wassermann Diagnostic Technologies, Inc. | Jun 24, 2008 | SESE |
| K041643 | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT | Beckman Coulter, Inc. | Aug 18, 2004 | SESE |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | Elan Diagnostics | Mar 7, 2003 | SESE |
| K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | Abaxis, Inc. | Sep 5, 2002 | SESE |
| K013095 | WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 | Wiener Laboratories Saic | Nov 16, 2001 | SESE |
| K003912 | PHOSPHORUS REAGENT | Jas Diagnostics, Inc. | Feb 21, 2001 | SESE |
| K003012 | RAICHEM PHOSPORUS REAGENT | Hemagen Diagnostics, Inc. | Oct 25, 2000 | SESE |
| K991867 | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | Aug 2, 1999 | SESE |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Boehringer Mannheim Corp. | Dec 1, 1998 | SESE |
| K981769 | HICHEM PHOSPHORUS REAGENT KIT | Elan Pharma, Inc. | Jun 29, 1998 | SESE |
| K981610 | CARESIDE ANALYZER | Careside, Inc. | Jun 25, 1998 | SESE |
| K981759 | PHOS | Abbott Laboratories | Jun 16, 1998 | SESE |
| K981118 | PHOS | Abbott Laboratories | Jun 12, 1998 | SESE |
| K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 | Diagnostic Chemicals , Ltd. | Jan 30, 1998 | SESE |
| K974605 | RANDOX INORGANIC PHOSPHOROUS | Randox Laboratories, Ltd. | Jan 9, 1998 | SESE |
| K971363 | SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT | Carolina Liquid Chemistries Corp. | Apr 21, 1997 | SESE |
| K955937 | INORGANIC PHOSPHORUS REAGENT | Derma Media Lab., Inc. | Mar 12, 1996 | SESE |
| K944768 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus America, Inc. | Mar 24, 1995 | SESE |
| K942960 | PHOSPHATE QVET | Prisma Systems | Dec 9, 1994 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 10 clearances
- Harleco — 5 clearances
- Abbott Laboratories — 4 clearances
- American Research Products Co. — 4 clearances
- Data Medical Associates, Inc. — 3 clearances
