Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CEO — Predicate Candidate Screening
105 FDA 510(k) clearances under this product code; the 50 most recent screened below.
39 daysmedian FDA review time
87 days90th percentile
105clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K100263 | ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND U | Seppim S.A.S. | 2011-05-06 | 463 | 0 |
| K072141 | S40 CLINICAL ANALYZER, S TEST IP, S TEST UA | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-24 | 327 | 0 |
| K041643 | SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT | Beckman Coulter, Inc. | 2004-08-18 | 62 | 0 |
| K030015 | ATAC PAK PHOSPHORUS REAGENT | Elan Diagnostics | 2003-03-07 | 64 | 0 |
| K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | Abaxis, Inc. | 2002-09-05 | 50 | 0 |
| K013095 | WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X2 | Wiener Laboratories Saic | 2001-11-16 | 60 | 0 |
| K003912 | PHOSPHORUS REAGENT | Jas Diagnostics, Inc. | 2001-02-21 | 64 | 0 |
| K003012 | RAICHEM PHOSPORUS REAGENT | Hemagen Diagnostics, Inc. | 2000-10-25 | 29 | 0 |
| K991867 | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-08-02 | 62 | 0 |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC | Boehringer Mannheim Corp. | 1998-12-01 | 56 | 0 |
| K981769 | HICHEM PHOSPHORUS REAGENT KIT | Elan Pharma, Inc. | 1998-06-29 | 41 | 0 |
| K981610 | CARESIDE ANALYZER | Careside, Inc. | 1998-06-25 | 56 | 0 |
| K981759 | PHOS | Abbott Laboratories | 1998-06-16 | 28 | 2 |
| K981118 | PHOS | Abbott Laboratories | 1998-06-12 | 77 | 0 |
| K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 | Diagnostic Chemicals , Ltd. | 1998-01-30 | 32 | 0 |
| K974605 | RANDOX INORGANIC PHOSPHOROUS | Randox Laboratories, Ltd. | 1998-01-09 | 30 | 0 |
| K971363 | SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT | Carolina Liquid Chemistries Corp. | 1997-04-21 | 14 | 0 |
| K955937 | INORGANIC PHOSPHORUS REAGENT | Derma Media Lab., Inc. | 1996-03-12 | 82 | 0 |
| K944768 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus America, Inc. | 1995-03-24 | 178 | 0 |
| K942960 | PHOSPHATE QVET | Prisma Systems | 1994-12-09 | 169 | 0 |
| K945322 | PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 | Emd Chemicals, Inc. | 1994-12-07 | 36 | 0 |
| K945368 | PHOSPHORUS TEST (PHOS) | Emd Chemicals, Inc. | 1994-12-02 | 43 | 0 |
| K935178 | EMDS PHOSPHOROUS (PHOS) TEST | Em Diagnostic Systems, Inc. | 1993-12-17 | 52 | 0 |
| K931835 | OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT | Olympus Corp. | 1993-09-08 | 148 | 0 |
| K932729 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) | Eastman Kodak Company | 1993-08-03 | 57 | 0 |
| K931361 | IL TEST PHOSPHORUS | Instrumentation Laboratory CO | 1993-05-11 | 55 | 0 |
| K925057 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus Corp. | 1992-11-19 | 44 | 0 |
| K924470 | TWO PART INORGANIC PHOSPHORUS TEST | Em Diagnostic Systems, Inc. | 1992-10-14 | 42 | 0 |
| K923764 | SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-22 | 56 | 0 |
| K923564 | OLYMPUS INORGANIC PHOSPHORUS REAGENT | Olympus Corp. | 1992-08-18 | 32 | 0 |
| K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | Tech Intl. Co. | 1992-01-22 | 54 | 0 |
| K912809 | ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 | Em Diagnostic Systems, Inc. | 1991-08-12 | 48 | 0 |
| K912569 | SYNERMED PHOSPHORUS REAGENT KIT | Synermed, Inc. | 1991-07-17 | 36 | 0 |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Biochemical Trade, Inc. | 1991-02-27 | 35 | 0 |
| K903696 | OLYMPUS INORGANIC PHOSPHORUS | Em Diagnostic Systems, Inc. | 1990-09-12 | 28 | 0 |
| K901964 | PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 | American Research Products Co. | 1990-05-31 | 30 | 0 |
| K901807 | OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) | Em Diagnostic Systems, Inc. | 1990-05-02 | 12 | 0 |
| K901137 | CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) | Technicon Instruments Corp. | 1990-04-12 | 31 | 0 |
| K900977 | AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 | American Research Products Co. | 1990-04-11 | 39 | 0 |
| K900215 | COULTER PHOSPHORUS REAGENT | Coulter Corp. | 1990-02-08 | 22 | 0 |
| K895999 | PHOSPHORUS | American Monitor Corp. | 1990-01-11 | 90 | 0 |
| K890773 | HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 | Hichem Diagnostics | 1989-04-18 | 62 | 0 |
| K891218 | IQ/QCA PHOSPHORUS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-03-22 | 15 | 0 |
| K885041 | BIOTROL INORGANIC PHOSPHORUS | Biotrol, USA, Inc. | 1989-01-30 | 56 | 0 |
| K884735 | PHOSPHORUS TEST (PHOS) ITEM #65666 | Em Diagnostic Systems, Inc. | 1988-12-16 | 32 | 0 |
| K883962 | ROCHE REAGENT FOR INORGANIC PHOSPHORUS | Roche Diagnostic Systems, Inc. | 1988-11-29 | 70 | 0 |
| K881171 | PHOSPHORUS (INORGANIC) | Tech-Co, Inc. | 1988-04-28 | 38 | 0 |
| K880676 | INORGANIC PHOSPHORUS REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-24 | 34 | 0 |
| K874577 | KODAK EKTACHEM DT SLIDES (PHOS) | Eastman Kodak Company | 1988-01-21 | 76 | 0 |
| K874472 | INORGANIC PHOSPHORUS | Catachem, Inc. | 1987-12-22 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda