Encore Chemistry Analyzer
FDA 510(k) K830641 · Baker Instructions Corp.
510(k) numberK830641
Submission
- Device name
- Encore Chemistry Analyzer
- Applicant
- Baker Instructions Corp.
Mchenry, IL, US - Received
- March 1, 1983
- Decision date
- April 5, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJG – Analyzer, Chemistry, Centrifugal, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2140
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972409 | AG Chemistry Analyzer SystemJJG · Traditional | Landmark Scientific, Inc. | 08/28/1997SE |
| K942782 | Piccolo(Tm)JJG · Traditional | Abaxis, Inc. | 03/13/1995SE |
| K934592 | Epoc 2000 Point-Of-Care Analyzer and Epoc 5-CHEMISTRY Reagent RotorJJG · Traditional | Abaxis, Inc. | 04/06/1994SE |
| K920942 | Olympus AU800 Clinical Chemistry AnalyzerJJG · Traditional | Olympus Corp. | 06/10/1992SE |
| K910222 | Cobas AlphaJJG · Traditional | Roche Diagnostic Systems, Inc. | 02/27/1991SE |
| K903626 | Biomek Automated Laboratory Workstation W/GenelisaJJG · Traditional | Beckman Instruments, Inc. | 10/15/1990SE |
| K893854 | Cobas Fara II Centrifugal AnalyzerJJG · Traditional | Roche Diagnostic Systems, Inc. | 08/03/1989SE |
| K893641 | Cobas Fara Centrifugal AnalyzerJJG · Traditional | Roche Diagnostic Systems, Inc. | 07/20/1989SE |
| K885203 | Technicon Dax(Tm) SystemJJG · Traditional | Technicon Instruments Corp. | 03/28/1989SE |
| K871973 | Il Monarch 1000 Clinical Chemistry Analytical Sys.JJG · Traditional | Instrumentation Laboratory CO | 06/11/1987SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K882612 | System 9000 Diff Model Automated Cell CounterGKZ · Traditional | 09/07/1988SE |
| K873596 | Baker TDM Theophylline AssayKLS · Traditional | 10/20/1987SE |
| K870603 | System 9000 Automated Cell CounterGKL · Traditional | 03/31/1987SE |
| K854173 | Ucd Urine Specimen CollectorKNX · Traditional | 11/04/1985SE |
| K850386 | System 8000 Cell CounterGKL · Traditional | 05/02/1985SE |
| K833116 | Spirit Chemistry SystemJJE · Traditional | 11/07/1983SE |
| K832716 | Encore Chemistry AnalyzerJJG · Traditional | 10/04/1983SE |
| K821956 | Haem-C Plus Blood Reference ControlsJCN · Traditional | 07/30/1982SE |
| K811694 | Centrifichem Alt/Agpt Optimized ReagentCKA · Traditional | 07/01/1981SE |
Questions and answers
When was Encore Chemistry Analyzer cleared by the FDA?
Encore Chemistry Analyzer (K830641) received a 510(k) decision of Substantially Equivalent on April 5, 1983, 35 days after the submission was received.
What is the product code of K830641?
The FDA product code is JJG – Analyzer, Chemistry, Centrifugal, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2140.