FDA Product Code
FDA Product Code JJF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2170
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K052794 | ETI-MAX 3000 | DiaSorin, Inc. | 2006-03-31 | Traditional | PDF ↗ |
| K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | Arkray, Inc. | 2004-06-16 | Traditional | PDF ↗ |
| K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 | Roche Diagnostics Corp. | 2003-12-17 | Traditional | PDF ↗ |
| K013654 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER | Precision Systems, Inc. | 2002-06-05 | Traditional | PDF ↗ |
| K012966 | ROCHE COBAS TAQMAN ANALYZER | Roche Molecular Systems, Inc. | 2002-02-01 | Traditional | PDF ↗ |
| K993634 | CARESIDE ANALYZER | Careside, Inc. | 1999-12-02 | Traditional | PDF ↗ |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | Vital Scientific N.V. | 1998-03-13 | Traditional | PDF ↗ |
| K980056 | CARESIDE ANALYZER | Exigent Diagnostics, Inc. | 1998-03-06 | Traditional | PDF ↗ |
| K973177 | MAGO AUTOMATED EIA PROCESSOR | Diamedix Corp. | 1997-10-09 | Traditional | PDF ↗ |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | Synermed, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K964506 | ROCHE COBAS AMPLICOR ANALYZER | Roche Molecular Systems, Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K965103 | WINMAX SOFTWARE SYSTEMS | Diagnostic Products Corp. | 1997-05-09 | Traditional | PDF ↗ |
| K964409 | HCL - 200 BIOCHEMISTRY ANALYZER | Hcl Laboratory Systems, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K961209 | BRIO AUTOMATIC SAMPLINC UNIT | Seac S.R.L. | 1996-12-24 | Traditional | PDF ↗ |
| K943978 | WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS | Waters Chromatography Division | 1995-05-02 | Traditional | PDF ↗ |
| K942676 | SYNCHRON CX3 DELTA | Beckman-Diagnostic Systems Group | 1994-11-02 | Traditional | PDF ↗ |
| K925093 | SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA | Beckman Instruments, Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K912055 | SYVA EDMS | Syva Co. | 1991-06-10 | Traditional | PDF ↗ |
| K903357 | SYVA(R) ETS(R) PLUS SYSTEM | Syva Co. | 1990-09-27 | Traditional | PDF ↗ |
| K893768 | MODIFIED PK300 AUTOMATIC EIA ANALYZER | Olympus Corp. | 1989-08-15 | Traditional | PDF ↗ |
| K883298 | RECONDITIONED ASTRA (TM) 8 | Associated Electro-Medical Services, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K883350 | RECONDITIONED ASTRA(TM) 4 | Associated Electro-Medical Services, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1988-09-02 | Traditional | PDF ↗ |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Miles Laboratories, Inc. | 1987-10-28 | Traditional | PDF ↗ |
| K871486 | (FPIA) ASSAY BUFFER | Windsor Laboratories, Inc. | 1987-05-08 | Traditional | PDF ↗ |
| K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER | Kone Instruments, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K863245 | SYVA ETS SYSTEM | Syva Co. | 1987-03-13 | Traditional | PDF ↗ |
| K864834 | OLYMPUS PK300 | Olympus Corp. | 1987-02-20 | Traditional | PDF ↗ |
| K864236 | SYNCHRON CX3 | Beckman Instruments, Inc. | 1986-12-31 | Traditional | PDF ↗ |
| K852385 | HYBRITECH IMMUNOCHEMISTRY ANALYZER | Hybritech, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K851933 | CLINICAL CHEMISTRY ANALYTICAL SYSTEM | Allied Instrumentation Laboratory | 1985-06-10 | Traditional | PDF ↗ |
| K851542 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1985-05-10 | Traditional | PDF ↗ |
| K851172 | COBAS MIRA | Roche Diagnostic Systems, Inc. | 1985-05-02 | Traditional | PDF ↗ |
| K850999 | TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN | Technicon Instruments Corp. | 1985-04-08 | Traditional | PDF ↗ |
| K844586 | IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS | Instrumentation Laboratory CO | 1984-12-11 | Traditional | PDF ↗ |
| K840200 | PROGRESS SELECTIVE DHEMISTRY ANALYZ | Kone Instruments, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K833998 | QCA CHEMISTRY ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-01-30 | Traditional | PDF ↗ |
| K833804 | SHABAN 9865 IL#78637 JUNCTION BLOC | Shaban Mfg. Co. | 1984-01-13 | Traditional | PDF ↗ |
| K833154 | NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM | Nova Biomedical Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K833153 | NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU | Nova Biomedical Corp. | 1983-11-25 | Traditional | PDF ↗ |
| K831227 | COMPUR EASY TOUCH CHEMISTRY ANALYZER- | Worthington Diagnostic Systems | 1983-06-02 | Traditional | PDF ↗ |
| K830095 | RAPID CHEM ANALYZER II | Macomb Chemical Co. | 1983-01-28 | Traditional | PDF ↗ |
| K821583 | AMES/GILFORD OPTIMATE CLIN. CHEM & THER | Gilford Instrument Laboratories, Inc. | 1982-06-24 | Traditional | PDF ↗ |
| K820541 | MICROLYTE | Kone Instruments, Inc. | 1982-05-24 | Traditional | PDF ↗ |
| K820748 | POLI-MAK MODEL F-4 (FINAL | Pm America, Inc. | 1982-04-06 | Traditional | PDF ↗ |
| K820415 | 4150 ALPHA AMINO ACID ANALYZER | Lkb Instruments, Inc. | 1982-03-11 | Traditional | PDF ↗ |
| K803004 | AMINO ACID ANALYSER SYSTEM | Lkb Instruments, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802264 | WASH SOLUTION KIT, #88102 | Hi Chem, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K802398 | ELECTROLY TE CHEMISTRY ANALYZER | Instrumentation Laboratory CO | 1980-10-31 | Traditional | PDF ↗ |
| K802392 | ASTRA PRINTER PAPER #88112-CHLORIDE SILV | Hi Chem, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K790197 | REAGENT KIT, LANCER GLUCOSE | Sherwood Medical Industries | 1979-03-12 | Traditional | PDF ↗ |
| K790335 | HYCEL M | Hycel, Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K781442 | BECKMAN ASTRA SYSTEM | Beckman Instruments, Inc. | 1978-10-03 | Traditional | PDF ↗ |
| K781606 | MEPA-1 BLOOD ANALYZER | Medico Electronic, Inc. | 1978-10-03 | Traditional | PDF ↗ |
| K771821 | STAC SYSTEM | Technicon Instruments Corp. | 1977-11-07 | Traditional | PDF ↗ |
| K771939 | STAC SYSTEM-ADDI. ANALYTES | Technicon Instruments Corp. | 1977-11-03 | Traditional | PDF ↗ |
| K771513 | KEM-O-MAT | Coulter Electronics, Inc. | 1977-08-22 | Traditional | PDF ↗ |
Product code JJF · Class I · Clinical Chemistry. Data: openFDA.