JQW · Station, Pipetting And Diluting, For Clinical Use
Clinical Chemistry · 21 CFR 862.2750 · Class 1
Overview
| Product Code | JQW |
|---|---|
| Device Name | Station, Pipetting And Diluting, For Clinical Use |
| Regulation | 21 CFR 862.2750 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.
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 140)
Showing 20 most recent of 140 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023955 | BD VIPER INSTRUMENT | Becton, Dickinson & CO | Jun 24, 2003 | SESE |
| K973335 | QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) | Zenyx Scientific , Ltd. | Apr 30, 1998 | SESE |
| K980180 | 2700 SAMPLE MANAGER | Waters Corporation | Feb 12, 1998 | SESE |
| K970420 | MASTERCAP AM 5.0/MASTERCAP RM 5.0 | Pharmacia, Inc. | Jun 30, 1997 | SESE |
| K970616 | MINI SAMPLER PROCESSOR | Cavro Scientific Instruments, Inc. | Apr 21, 1997 | SESE |
| K962687 | GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM | Nichols Institute Diagnostics | Mar 28, 1997 | SESE |
| K962859 | MINI SAMPLE PROCESSOR | Cavro Scientific Instruments, Inc. | Oct 29, 1996 | SESE |
| K961896 | MICROLAB 4000, MICROLAB 4200 | Hamilton Co. | Aug 16, 1996 | SESE |
| K961694 | IMPACT | Matrix Technologies Corp. | Jun 21, 1996 | SESE |
| K953345 | GENESIS | Tecan U.S., Inc. | Nov 21, 1995 | SESE |
| K951753 | MEDTEC AUTOBLOT 2000 | Medtec, Inc. | Oct 17, 1995 | SESE |
| K952025 | ROBOCAP | Pharmacia, Inc. | Jul 26, 1995 | SESE |
| K944556 | 4 CHANNEL DISPENSER | Tecan U.S., Inc. | Oct 25, 1994 | SESE |
| K942655 | 4 CHANNEL DISPENSER | Tecan U.S., Inc. | Sep 2, 1994 | SESE |
| K942290 | STAR I WORKSTATION | Standard Engineering | Aug 26, 1994 | SESE |
| K941498 | BIOMEK SL WITH BIOMEK SL INCUBATOR | Beckman Analytical and Biotechnology Development | Jul 14, 1994 | SESE |
| K941394 | STAT FAX 2600 | Awareness Technology, Inc. | Jun 3, 1994 | SESE |
| K940390 | IMPACT | Matrix Technologies Corp. | May 3, 1994 | SESE |
| K936258 | SYSTEM WASHER 100 | Eg&G Berthold | Apr 26, 1994 | SESE |
| K934124 | AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM | Andronic Devices, Ltd. | Apr 13, 1994 | SESE |
Top Applicants
- Denley Instruments, Inc. — 8 clearances
- Dynatech Laboratories, Inc. — 7 clearances
- Micromedic Systems — 6 clearances
- Hamilton Co. — 6 clearances
- Diagnostic Products Corp. — 5 clearances
