Product code JJF
- Device name
- Analyzer, Chemistry, Micro, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2170
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052794 | ETI-MAX 3000 | DiaSorin, Inc. | 2006-03-31 |
| K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | Arkray, Inc. | 2004-06-16 |
| K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 | Roche Diagnostics Corp. | 2003-12-17 |
| K013654 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER | Precision Systems, Inc. | 2002-06-05 |
| K012966 | ROCHE COBAS TAQMAN ANALYZER | Roche Molecular Systems, Inc. | 2002-02-01 |
| K993634 | CARESIDE ANALYZER | Careside, Inc. | 1999-12-02 |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | Vital Scientific N.V. | 1998-03-13 |
| K980056 | CARESIDE ANALYZER | Exigent Diagnostics, Inc. | 1998-03-06 |
| K973177 | MAGO AUTOMATED EIA PROCESSOR | Diamedix Corp. | 1997-10-09 |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | Synermed, Inc. | 1997-06-26 |
| K964506 | ROCHE COBAS AMPLICOR ANALYZER | Roche Molecular Systems, Inc. | 1997-05-21 |
| K965103 | WINMAX SOFTWARE SYSTEMS | Diagnostic Products Corp. | 1997-05-09 |
| K964409 | HCL - 200 BIOCHEMISTRY ANALYZER | Hcl Laboratory Systems, Inc. | 1997-01-22 |
| K961209 | BRIO AUTOMATIC SAMPLINC UNIT | Seac S.R.L. | 1996-12-24 |
| K943978 | WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS | Waters Chromatography Division | 1995-05-02 |
| K942676 | SYNCHRON CX3 DELTA | Beckman-Diagnostic Systems Group | 1994-11-02 |
| K925093 | SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA | Beckman Instruments, Inc. | 1993-11-16 |
| K912055 | SYVA EDMS | Syva Co. | 1991-06-10 |
| K903357 | SYVA(R) ETS(R) PLUS SYSTEM | Syva Co. | 1990-09-27 |
| K893768 | MODIFIED PK300 AUTOMATIC EIA ANALYZER | Olympus Corp. | 1989-08-15 |
| K883350 | RECONDITIONED ASTRA(TM) 4 | Associated Electro-Medical Services, Inc. | 1989-03-16 |
| K883298 | RECONDITIONED ASTRA (TM) 8 | Associated Electro-Medical Services, Inc. | 1989-03-16 |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | 1988-09-02 |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | Miles Laboratories, Inc. | 1987-10-28 |
| K871486 | (FPIA) ASSAY BUFFER | Windsor Laboratories, Inc. | 1987-05-08 |
| K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER | Kone Instruments, Inc. | 1987-03-13 |
| K863245 | SYVA ETS SYSTEM | Syva Co. | 1987-03-13 |
| K864834 | OLYMPUS PK300 | Olympus Corp. | 1987-02-20 |
| K864236 | SYNCHRON CX3 | Beckman Instruments, Inc. | 1986-12-31 |
| K852385 | HYBRITECH IMMUNOCHEMISTRY ANALYZER | Hybritech, Inc. | 1985-07-12 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810039380307 | Cholestech LDX™ | Alere San Diego, Inc. | 2023-12-20 |
| 00810039380512 | Cholestech LDX™ | Alere San Diego, Inc. | 2023-12-20 |
| 05055273205893 | RX daytona | RANDOX LABORATORIES LIMITED | 2018-06-07 |
| 00854361008003 | Alere Cholestech LDX® | Alere San Diego, Inc. | 2018-03-30 |
| 03661540600180 | V-Twin® | VitalScientific B.V. | 2016-11-21 |
| 00725609000502 | SPOTCHECK | ASTORIA-PACIFIC, INC. | 2016-10-14 |
| 00725609000496 | SPOTCHECK | ASTORIA-PACIFIC, INC. | 2016-10-14 |
| 00817439021373 | MedTest DX Wash Solution for the BS200 | Medtest Dx, Inc. | 2016-09-27 |
| 00817439020086 | Wash Concentrate 3 | Medtest Dx, Inc. | 2016-09-27 |
| 00817439020079 | Wash Concentrate 2 | Medtest Dx, Inc. | 2016-09-27 |
| 00817439020062 | Wash Concentrate 1 | Medtest Dx, Inc. | 2016-09-27 |
| 05055273206050 | WASH conc. 1 | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273210361 | SOLN WASH | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273206982 | AWS | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273206289 | SABS | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273206111 | NS | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273206074 | Cl SOLN | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273206043 | WASH conc. 2 | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273205961 | ISE DIL URN | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273205947 | WASH conc. 3 | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 05055273205091 | RABS | RANDOX LABORATORIES LIMITED | 2016-09-26 |
| 08056771102148 | LIAISON® XL | DIASORIN SPA | 2016-09-24 |
| 00817273020464 | Diamedix | DIAMEDIX CORPORATION | 2016-09-21 |
| 00817273020471 | Diamedix | DIAMEDIX CORPORATION | 2016-09-21 |
| 04015630924691 | cobas 6000 core unit | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630925551 | cobas c 311 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630924707 | cobas c 501 Module | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630924745 | COBAS®TaqMan® 48 Analyzer | Roche Molecular Systems, Inc. | 2014-09-17 |
| 04015630925537 | COBAS® TaqMan® | Roche Molecular Systems, Inc. | 2014-09-15 |