JJF · Analyzer, Chemistry, Micro, For Clinical Use
Clinical Chemistry · 21 CFR 862.2170 · Class 1
Overview
| Product Code | JJF |
|---|---|
| Device Name | Analyzer, Chemistry, Micro, For Clinical Use |
| Regulation | 21 CFR 862.2170 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052794 | ETI-MAX 3000 | DiaSorin, Inc. | Mar 31, 2006 | SESE |
| K040332 | POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER | Arkray, Inc. | Jun 16, 2004 | SESE |
| K033734 | LIGHTCYCLER INSTRUMENT VERSION 1.2 | Roche Diagnostics Corp. | Dec 17, 2003 | SESE |
| K013654 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER | Precision Systems, Inc. | Jun 5, 2002 | SESE |
| K012966 | ROCHE COBAS TAQMAN ANALYZER | Roche Molecular Systems, Inc. | Feb 1, 2002 | SESE |
| K993634 | CARESIDE ANALYZER | Careside, Inc. | Dec 2, 1999 | SESE |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | Vital Scientific N.V. | Mar 13, 1998 | SESE |
| K980056 | CARESIDE ANALYZER | Exigent Diagnostics, Inc. | Mar 6, 1998 | SESE |
| K973177 | MAGO AUTOMATED EIA PROCESSOR | Diamedix Corp. | Oct 9, 1997 | SESE |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | Synermed, Inc. | Jun 26, 1997 | SESE |
| K964506 | ROCHE COBAS AMPLICOR ANALYZER | Roche Molecular Systems, Inc. | May 21, 1997 | SESE |
| K965103 | WINMAX SOFTWARE SYSTEMS | Diagnostic Products Corp. | May 9, 1997 | SESE |
| K964409 | HCL - 200 BIOCHEMISTRY ANALYZER | Hcl Laboratory Systems, Inc. | Jan 22, 1997 | SESE |
| K961209 | BRIO AUTOMATIC SAMPLINC UNIT | Seac S.R.L. | Dec 24, 1996 | SESE |
| K943978 | WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS | Waters Chromatography Division | May 2, 1995 | SESE |
| K942676 | SYNCHRON CX3 DELTA | Beckman-Diagnostic Systems Group | Nov 2, 1994 | SESE |
| K925093 | SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA | Beckman Instruments, Inc. | Nov 16, 1993 | SESE |
| K912055 | SYVA EDMS | Syva Co. | Jun 10, 1991 | SESE |
| K903357 | SYVA(R) ETS(R) PLUS SYSTEM | Syva Co. | Sep 27, 1990 | SESE |
| K893768 | MODIFIED PK300 AUTOMATIC EIA ANALYZER | Olympus Corp. | Aug 15, 1989 | SESE |
Top Applicants
- Technicon Instruments Corp. — 3 clearances
- Syva Co. — 3 clearances
- Kone Instruments, Inc. — 3 clearances
- Beckman Instruments, Inc. — 3 clearances
- Roche Molecular Systems, Inc. — 2 clearances
