FDA Product Code
FDA Product Code CEO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1580
510(k) Clearances — 105 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS | Seppim S.A.S. | 2011-05-06 | Traditional | PDF ↗ |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | Traditional | PDF ↗ |
| K041643 | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT | Beckman Coulter, Inc. | 2004-08-18 | Traditional | PDF ↗ |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | Elan Diagnostics | 2003-03-07 | Traditional | PDF ↗ |
| K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | Abaxis, Inc. | 2002-09-05 | Traditional | PDF ↗ |
| K013095 | WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 | Wiener Laboratories Saic | 2001-11-16 | Traditional | PDF ↗ |
| K003912 | PHOSPHORUS REAGENT | Jas Diagnostics, Inc. | 2001-02-21 | Traditional | PDF ↗ |
| K003012 | RAICHEM PHOSPORUS REAGENT | Hemagen Diagnostics, Inc. | 2000-10-25 | Special | PDF ↗ |
| K991867 | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Boehringer Mannheim Corp. | 1998-12-01 | Traditional | PDF ↗ |
| K981769 | HICHEM PHOSPHORUS REAGENT KIT | Elan Pharma, Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K981610 | CARESIDE ANALYZER | Careside, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K981759 | PHOS | Abbott Laboratories | 1998-06-16 | Traditional | PDF ↗ |
| K981118 | PHOS | Abbott Laboratories | 1998-06-12 | Traditional | PDF ↗ |
| K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 | Diagnostic Chemicals , Ltd. | 1998-01-30 | Traditional | PDF ↗ |
| K974605 | RANDOX INORGANIC PHOSPHOROUS | Randox Laboratories, Ltd. | 1998-01-09 | Traditional | PDF ↗ |
| K971363 | SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT | Carolina Liquid Chemistries Corp. | 1997-04-21 | Traditional | PDF ↗ |
| K955937 | INORGANIC PHOSPHORUS REAGENT | Derma Media Lab., Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K944768 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus America, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K942960 | PHOSPHATE QVET | Prisma Systems | 1994-12-09 | Traditional | PDF ↗ |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | Emd Chemicals, Inc. | 1994-12-07 | Traditional | PDF ↗ |
| K945368 | PHOSPHORUS TEST (PHOS) | Emd Chemicals, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Em Diagnostic Systems, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K931835 | OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT | Olympus Corp. | 1993-09-08 | Traditional | PDF ↗ |
| K932729 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) | Eastman Kodak Company | 1993-08-03 | Traditional | PDF ↗ |
| K931361 | IL TEST PHOSPHORUS | Instrumentation Laboratory CO | 1993-05-11 | Traditional | PDF ↗ |
| K925057 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus Corp. | 1992-11-19 | Traditional | PDF ↗ |
| K924470 | TWO PART INORGANIC PHOSPHORUS TEST | Em Diagnostic Systems, Inc. | 1992-10-14 | Traditional | PDF ↗ |
| K923764 | SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K923564 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus Corp. | 1992-08-18 | Traditional | PDF ↗ |
| K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | Tech Intl. Co. | 1992-01-22 | Traditional | PDF ↗ |
| K912809 | ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 | Em Diagnostic Systems, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K912569 | SYNERMED PHOSPHORUS REAGENT KIT | Synermed, Inc. | 1991-07-17 | Traditional | PDF ↗ |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Biochemical Trade, Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K903696 | OLYMPUS INORGANIC PHOSPHORUS | Em Diagnostic Systems, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K901964 | PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 | American Research Products Co. | 1990-05-31 | Traditional | PDF ↗ |
| K901807 | OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) | Em Diagnostic Systems, Inc. | 1990-05-02 | Traditional | PDF ↗ |
| K901137 | CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) | Technicon Instruments Corp. | 1990-04-12 | Traditional | PDF ↗ |
| K900977 | AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 | American Research Products Co. | 1990-04-11 | Traditional | PDF ↗ |
| K900215 | COULTER PHOSPHORUS REAGENT | Coulter Corp. | 1990-02-08 | Traditional | PDF ↗ |
| K895999 | PHOSPHORUS | American Monitor Corp. | 1990-01-11 | Traditional | PDF ↗ |
| K890773 | HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 | Hichem Diagnostics | 1989-04-18 | Traditional | PDF ↗ |
| K891218 | IQ/QCA PHOSPHORUS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-03-22 | Traditional | PDF ↗ |
| K885041 | BIOTROL INORGANIC PHOSPHORUS | Biotrol, USA, Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K884735 | PHOSPHORUS TEST (PHOS) ITEM #65666 | Em Diagnostic Systems, Inc. | 1988-12-16 | Traditional | PDF ↗ |
| K883962 | ROCHE REAGENT FOR INORGANIC PHOSPHORUS | Roche Diagnostic Systems, Inc. | 1988-11-29 | Traditional | PDF ↗ |
| K881171 | PHOSPHORUS (INORGANIC) | Tech-Co, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880676 | INORGANIC PHOSPHORUS REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K874577 | KODAK EKTACHEM DT SLIDES (PHOS) | Eastman Kodak Company | 1988-01-21 | Traditional | PDF ↗ |
| K874472 | INORGANIC PHOSPHORUS | Catachem, Inc. | 1987-12-22 | Traditional | PDF ↗ |
| K873454 | PARAMAX PHOSPHORUS REAGENT | Baxter Healthcare Corp | 1987-11-23 | Traditional | PDF ↗ |
| K874153 | EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 | Em Diagnostic Systems, Inc. | 1987-11-04 | Traditional | PDF ↗ |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | Simmler, Inc. | 1987-10-28 | Traditional | PDF ↗ |
| K870368 | PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION | Trace Scientific , Ltd. | 1987-08-19 | Traditional | PDF ↗ |
| K871321 | FLOW-PAC INORGANIC PHOSPHORUS REAGENTS | American Research Products Co. | 1987-04-22 | Traditional | PDF ↗ |
| K870776 | RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT | Reagents Applications, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K863718 | EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 | Em Diagnostic Systems, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K863088 | ABBOTT SPECTRUM PHOSPHORUS REAGENT | Abbott Laboratories | 1986-09-25 | Traditional | PDF ↗ |
| K863264 | INORGANIC PHOSPHORUS PROCEDURE | Data Medical Associates, Inc. | 1986-09-11 | Traditional | PDF ↗ |
| K863072 | FOSFOROMETER | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K862834 | MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1986-08-19 | Traditional | PDF ↗ |
| K861661 | INORGANIC PHOSPHORUS PROCEDURE | Data Medical Associates, Inc. | 1986-07-01 | Traditional | PDF ↗ |
| K861968 | AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET | American Research Products Co. | 1986-06-13 | Traditional | PDF ↗ |
| K860628 | INORGANIC PHOSPHORUS REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K855154 | INORGANIC PHOSPHORUS REAGENT SET | Technostics Intl. | 1986-01-14 | Traditional | PDF ↗ |
| K854188 | IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO | Clinical Data, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K850934 | PHOSPHORUS | Dilab, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K852003 | IP ACID REAGENT IP MOLY BDATE REAGENT | Alpkem Corp. | 1985-05-31 | Traditional | PDF ↗ |
| K852103 | INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN | Medical Analysis Systems, Inc. | 1985-05-31 | Traditional | PDF ↗ |
| K850986 | DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE | Data Medical Associates, Inc. | 1985-04-01 | Traditional | PDF ↗ |
| K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER | Advanced Biomedical Methods, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K844316 | RAICHEM PHOSPHORUS REAGENT | Reagents Applications, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K844182 | INORGANIC PHOSPHORUS REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-09 | Traditional | PDF ↗ |
| K843177 | INORGANIC PHOSPHORUS TEST | Sclavo, Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K843330 | SYSTEMATE PHOSPHORUS 67217 | Em Diagnostic Systems, Inc. | 1984-09-14 | Traditional | PDF ↗ |
| K843030 | INORGANIC PHOSPHORUS ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-27 | Traditional | PDF ↗ |
| K841181 | ASTRA SYS INORGANIC PHOSPHORUS CHEM | Beckman Instruments, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K841061 | PHOPHORUS REAGNET SET | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840215 | PHOSPHORUS REAGENT SYSTEM | Sclavo, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K833002 | PARAMAX PHOSPHORUS REAGENT | American Dade | 1983-10-14 | Traditional | PDF ↗ |
| K823691 | PHOSPHORUS REAGENT SET | Omega Medical Electronics | 1983-01-07 | Traditional | PDF ↗ |
| K823580 | COBAS REAGENT FOR INORGANIC PHOSPHORUS | Hoffmann-La Roche, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K822470 | PSI INORGANIC PHOSPHORUS | Pointe Scientific, Inc., | 1982-09-14 | Traditional | PDF ↗ |
| K821874 | ULTRACHEM PHOS | Harleco Diagnostics | 1982-07-13 | Traditional | PDF ↗ |
| K813400 | INORGANIC PHOSPHORUS REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-22 | Traditional | PDF ↗ |
| K811749 | KING DIAGNOSTICS PHOSPHORUS TEST | King Diagnostics, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K802159 | AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS | Panmed, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K800690 | REAGENT FOR DETERM. INORGANIC/PHOSPHORUS | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800297 | SANDARE FAST 340 PHOSPHOROUS PROCEDURE | Sandare Chemical Co., Inc. | 1980-03-05 | Traditional | PDF ↗ |
| K792401 | ELVI INORGANIC PHOSPHOROUS | Volu Sol Medical Industries | 1979-12-07 | Traditional | PDF ↗ |
| K791708 | INORGANIC PHOSPHORUS REAGENT | Gilford Diagnostics | 1979-09-24 | Traditional | PDF ↗ |
| K790021 | SERUM, INORGANIC PHOSPHOROUS | Fisher Scientific Co., LLC | 1979-02-15 | Traditional | PDF ↗ |
| K781806 | REAGENT SYSTEM, INORGANIC PHOSPHORUS | Sigma Chemical Co. | 1979-01-17 | Traditional | PDF ↗ |
| K781000 | PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS | Abbott Laboratories | 1978-12-04 | Traditional | PDF ↗ |
| K772156 | ULTRACHEM PHOSPHORUS, 64973 | Harleco | 1977-12-06 | Traditional | PDF ↗ |
| K771835 | INORGANIC PHOSPHORUS | Gamma Enterprises, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K771848 | PHOSPHORUS TEST KIT | Mallinckrodt Critical Care | 1977-10-28 | Traditional | PDF ↗ |
| K771477 | MULTISTAT III PHOSPHOROUS TEST | Instrumentation Laboratory CO | 1977-09-12 | Traditional | PDF ↗ |
| K770820 | ULTRACHEM INORGANIC PHOSPHORUS | Harleco | 1977-07-11 | Traditional | PDF ↗ |
| K770456 | PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT | Icn Pharmaceuticals, Inc. | 1977-05-03 | Traditional | PDF ↗ |
Product code CEO · Class I · Clinical Chemistry. Data: openFDA.