Panels › Clinical Chemistry › Product code JJF · Class 1
Analyzer, Chemistry, Micro, For Clinical Use
Regulation 862.2170
0510(k)s in 12 months (57 all time)
0recalls in 12 months (13 all time)
10recalls that name a 510(k)
Top companies in JJF
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 2 | 5 |
| Vital Scientific N.V. | 1 | 6 |
| Beckman Instruments, Inc. | 3 | 0 |
| Kone Instruments, Inc. | 3 | 0 |
| Syva Co. | 3 | 0 |
| Technicon Instruments Corp. | 3 | 0 |
| Alpkem Corp. | 2 | 0 |
| Associated Electro-Medical Services, Inc. | 2 | 0 |
| Hi Chem, Inc. | 2 | 0 |
| Instrumentation Laboratory CO | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2018 | Vital Scientific N.V. V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 Open, Classified |
JJF | K973628 |
| Sep 7, 2018 | Vital Scientific N.V. V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with cert Terminated |
JJF | None listed |
| Jan 18, 2016 | Vital Scientific N.V. V-Twin, Model # 6002-800, UDI: 03661540600180
Product Usage:
An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain Open, Classified |
JJF | K973628 |
| Aug 15, 2012 | Roche Molecular Systems, Inc. COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode Terminated |
JJF | None listed |
| Jan 10, 2012 | Vital Scientific N.V. V-Twin, Catalog # 6002-800, UDI # 03661540600180
Product Usage: automated chemistry analyzer intended for clinical use Terminated |
JJF | K973628 |
| Jan 10, 2012 | Vital Scientific N.V. Viva-E, Catalog # 6002-380, UDI # 03661540600050
Product Usage: automated chemistry analyzer intended for clinical use Terminated |
JJF | K973628 |
| Jan 10, 2012 | Vital Scientific N.V. Viva - JR, catalog # 6002-940, UDI # 03661540600210
Product Usage: automated chemistry analyzer intended for clinical use Terminated |
JJF | K973628 |
| Dec 12, 2007 | Roche Diagnostics Corp. Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightC Terminated |
JJF | K033734 |
| Aug 2, 2007 | Roche Molecular Systems, Inc. Amplilink Software versions 1.1, 1.3, 1.4, 2.41.
COBAS Amplicor CTA & NGA Tests Terminated |
JJF | K964506 |
| Jan 11, 2006 | Beckman Coulter Inc Cytomics FC500 with
CXP Software Terminated |
JJF | None listed |
| Jul 27, 2004 | Roche Molecular Systems Inc COBAS TaqMan 48 Analyzers. Terminated |
JJF | K012966 |
| Jul 27, 2004 | Roche Molecular Systems Inc COBAS TaqMan Analyzer Terminated |
JJF | K012966 |
| Jun 5, 2003 | Roche Molecular Systems Inc COBAS TaqMan analyzer, Series 96; catalog number 8080216. Terminated |
JJF | K012966 |
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