Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JJF — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
211 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052794 | ETI-MAX 3000 | DiaSorin, Inc. | 2006-03-31 | 179 | 0 |
| K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | Arkray, Inc. | 2004-06-16 | 127 | 0 |
| K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 | Roche Diagnostics Corp. | 2003-12-17 | 19 | 1 |
| K013654 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER | Precision Systems, Inc. | 2002-06-05 | 211 | 0 |
| K012966 | ROCHE COBAS TAQMAN ANALYZER | Roche Molecular Systems, Inc. | 2002-02-01 | 150 | 3 |
| K993634 | CARESIDE ANALYZER | Careside, Inc. | 1999-12-02 | 36 | 0 |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | Vital Scientific N.V. | 1998-03-13 | 170 | 0 |
| K980056 | CARESIDE ANALYZER | Exigent Diagnostics, Inc. | 1998-03-06 | 59 | 0 |
| K973177 | MAGO AUTOMATED EIA PROCESSOR | Diamedix Corp. | 1997-10-09 | 45 | 0 |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | Synermed, Inc. | 1997-06-26 | 63 | 0 |
| K964506 | ROCHE COBAS AMPLICOR ANALYZER | Roche Molecular Systems, Inc. | 1997-05-21 | 194 | 1 |
| K965103 | WINMAX SOFTWARE SYSTEMS | Diagnostic Products Corp. | 1997-05-09 | 140 | 0 |
| K964409 | HCL - 200 BIOCHEMISTRY ANALYZER | Hcl Laboratory Systems, Inc. | 1997-01-22 | 79 | 0 |
| K961209 | BRIO AUTOMATIC SAMPLINC UNIT | Seac S.R.L. | 1996-12-24 | 271 | 0 |
| K943978 | WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS | Waters Chromatography Division | 1995-05-02 | 259 | 0 |
| K942676 | SYNCHRON CX3 DELTA | Beckman-Diagnostic Systems Group | 1994-11-02 | 149 | 0 |
| K925093 | SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA | Beckman Instruments, Inc. | 1993-11-16 | 405 | 0 |
| K912055 | SYVA EDMS | Syva Co. | 1991-06-10 | 32 | 0 |
| K903357 | SYVA(R) ETS(R) PLUS SYSTEM | Syva Co. | 1990-09-27 | 63 | 0 |
| K893768 | MODIFIED PK300 AUTOMATIC EIA ANALYZER | Olympus Corp. | 1989-08-15 | 88 | 0 |
| K883298 | RECONDITIONED ASTRA (TM) 8 | Associated Electro-Medical Services, Inc. | 1989-03-16 | 224 | 0 |
| K883350 | RECONDITIONED ASTRA(TM) 4 | Associated Electro-Medical Services, Inc. | 1989-03-16 | 219 | 0 |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1988-09-02 | 45 | 0 |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Miles Laboratories, Inc. | 1987-10-28 | 149 | 0 |
| K871486 | (FPIA) ASSAY BUFFER | Windsor Laboratories, Inc. | 1987-05-08 | 23 | 0 |
| K863245 | SYVA ETS SYSTEM | Syva Co. | 1987-03-13 | 203 | 0 |
| K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER | Kone Instruments, Inc. | 1987-03-13 | 15 | 0 |
| K864834 | OLYMPUS PK300 | Olympus Corp. | 1987-02-20 | 73 | 0 |
| K864236 | SYNCHRON CX3 | Beckman Instruments, Inc. | 1986-12-31 | 64 | 0 |
| K852385 | HYBRITECH IMMUNOCHEMISTRY ANALYZER | Hybritech, Inc. | 1985-07-12 | 37 | 0 |
| K851933 | CLINICAL CHEMISTRY ANALYTICAL SYSTEM | Allied Instrumentation Laboratory | 1985-06-10 | 39 | 0 |
| K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1985-05-10 | 24 | 0 |
| K851172 | COBAS MIRA | Roche Diagnostic Systems, Inc. | 1985-05-02 | 41 | 0 |
| K850999 | TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN | Technicon Instruments Corp. | 1985-04-08 | 28 | 0 |
| K844586 | IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS | Instrumentation Laboratory CO | 1984-12-11 | 18 | 0 |
| K840200 | PROGRESS SELECTIVE DHEMISTRY ANALYZ | Kone Instruments, Inc. | 1984-04-04 | 76 | 0 |
| K833998 | QCA CHEMISTRY ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-01-30 | 70 | 0 |
| K833804 | SHABAN 9865 IL#78637 JUNCTION BLOC | Shaban Mfg. Co. | 1984-01-13 | 73 | 0 |
| K833154 | NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM | Nova Biomedical Corp. | 1983-12-08 | 84 | 0 |
| K833153 | NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU | Nova Biomedical Corp. | 1983-11-25 | 71 | 0 |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | Worthington Diagnostic Systems | 1983-06-02 | 48 | 0 |
| K830095 | RAPID CHEM ANALYZER II | Macomb Chemical Co. | 1983-01-28 | 17 | 0 |
| K821583 | AMES/GILFORD OPTIMATE CLIN. CHEM & THER | Gilford Instrument Laboratories, Inc. | 1982-06-24 | 27 | 0 |
| K820541 | MICROLYTE | Kone Instruments, Inc. | 1982-05-24 | 83 | 0 |
| K820748 | POLI-MAK MODEL F-4 (FINAL | Pm America, Inc. | 1982-04-06 | 18 | 0 |
| K820415 | 4150 ALPHA AMINO ACID ANALYZER | Lkb Instruments, Inc. | 1982-03-11 | 27 | 0 |
| K803004 | AMINO ACID ANALYSER SYSTEM | Lkb Instruments, Inc. | 1980-12-22 | 26 | 0 |
| K802398 | ELECTROLY TE CHEMISTRY ANALYZER | Instrumentation Laboratory CO | 1980-10-31 | 29 | 0 |
| K802264 | WASH SOLUTION KIT, #88102 | Hi Chem, Inc. | 1980-10-31 | 45 | 0 |
| K802392 | ASTRA PRINTER PAPER #88112-CHLORIDE SILV | Hi Chem, Inc. | 1980-10-23 | 21 | 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