JJC · Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Clinical Chemistry · 21 CFR 862.2150 · Class 1
Overview
| Product Code | JJC |
|---|---|
| Device Name | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use |
| Regulation | 21 CFR 862.2150 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. 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 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945915 | AVL OMNI ANALYZER | Avl Scientific Corp. | Apr 5, 1995 | SESE |
| K945584 | NOVA 16 ANALYZER | Nova Biomedical Corp. | Feb 8, 1995 | SESE |
| K943376 | OPERA SYSTEM | Miles, Inc. | Sep 14, 1994 | SESE |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | Technicon Instruments Corp. | Jul 17, 1990 | SESE |
| K901141 | PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX | Baxter Healthcare Corp | Apr 9, 1990 | SESE |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Alpkem Corp. | Feb 17, 1989 | SESE |
| K881056 | AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 | American Research Products Co. | Nov 15, 1988 | SESE |
| K875105 | TECHNICON SMAC 3 SYSTEM | Technicon Instruments Corp. | Feb 16, 1988 | SESE |
| K870998 | TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS | Technicon Instruments Corp. | May 26, 1987 | SESE |
| K862561 | TECHNICON RA-XT SYSTEM WITH ANALYTES | Technicon Instruments Corp. | Oct 20, 1986 | SESE |
| K854345 | TECHNICON RA-500 SYSTEM | Technicon Instruments Corp. | Nov 26, 1985 | SESE |
| K852306 | REPLACEMENT REAGENTS FOR SMAC II SYSTEMS | Methodist Hospital of Memphis | Aug 2, 1985 | SESE |
| K833157 | LANCER ANALYZER CUPS | Sherwood Medical Co. | Dec 8, 1983 | SESE |
| K833023 | TECHNICON RA-1000 SYSTEM | Technicon Instruments Corp. | Nov 3, 1983 | SESE |
| K823233 | SBA 300 CLINICAL CHEMISTRY ANALYZER | Gilford Instrument Laboratories, Inc. | Nov 29, 1982 | SESE |
| K813077 | TECHNICON RA 1000 SYSTEM | Technicon Corp. | Nov 16, 1981 | SESE |
| K811249 | TECHNICON SMAC II SYSTEM & ACCESSORIES | Technicon Instruments Corp. | May 21, 1981 | SESE |
| K810394 | PRE-VAP CAPS | Sherman Boosalis | Mar 6, 1981 | SESE |
| K801481 | BMC RIAFLO SYSTEM | Boehringer Mannheim Corp. | Aug 20, 1980 | SESE |
| K800587 | NSI WASH SOLUTION CONCENTRATE | Nobel Scientific Industries, Inc. | Aug 8, 1980 | SESE |
Top Applicants
- Technicon Instruments Corp. — 12 clearances
- Gilford Instrument Laboratories, Inc. — 2 clearances
- Alpkem Corp. — 1 clearance
- American Research Products Co. — 1 clearance
- Avl Scientific Corp. — 1 clearance
