FDA 510(k) Applications for Medical Device Product Code "JJF"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K040332 | ARKRAY, INC. | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | 06/16/2004 |
K993634 | CARESIDE, INC. | CARESIDE ANALYZER | 12/02/1999 |
K965103 | DIAGNOSTIC PRODUCTS CORP. | WINMAX SOFTWARE SYSTEMS | 05/09/1997 |
K973177 | DIAMEDIX CORP. | MAGO AUTOMATED EIA PROCESSOR | 10/09/1997 |
K052794 | DIASORIN, INC. | ETI-MAX 3000 | 03/31/2006 |
K980056 | EXIGENT DIAGNOSTICS, INC. | CARESIDE ANALYZER | 03/06/1998 |
K964409 | HCL LABORATORY SYSTEMS, INC. | HCL - 200 BIOCHEMISTRY ANALYZER | 01/22/1997 |
K013654 | PRECISION SYSTEMS, INC. | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER | 06/05/2002 |
K033734 | ROCHE DIAGNOSTICS CORP. | LIGHTCYCLER INSTRUMENT VERSION 1.2 | 12/17/2003 |
K964506 | ROCHE MOLECULAR SYSTEMS, INC. | ROCHE COBAS AMPLICOR ANALYZER | 05/21/1997 |
K012966 | ROCHE MOLECULAR SYSTEMS, INC. | ROCHE COBAS TAQMAN ANALYZER | 02/01/2002 |
K961209 | SEAC S.R.L. | BRIO AUTOMATIC SAMPLINC UNIT | 12/24/1996 |
K971491 | SYNERMED, INC. | SYNERMED IR 200 CHEMISTRY ANALYZER | 06/26/1997 |
K973628 | VITAL SCIENTIFIC N.V. | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | 03/13/1998 |