Epoc 2000 Point-Of-Care Analyzer and Epoc 5-CHEMISTRY Reagent Rotor
FDA 510(k) K934592 · Abaxis, Inc.
510(k) numberK934592
Submission
- Device name
- Epoc 2000 Point-Of-Care Analyzer and Epoc 5-CHEMISTRY Reagent Rotor
- Applicant
- Abaxis, Inc.
Sunnyvale, CA, US - Received
- September 24, 1993
- Decision date
- April 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K871838 | Biomek 1000C Automated Laboratory Work StationJJG · Traditional | Beckman Instruments, Inc. | 05/26/1987SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200865 | Piccolo Potassium Test SystemMZV · Dual Track | 10/20/2021SE |
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | 03/11/2013SE |
| K130200 | Piccolo Total Cholesterol - Capillary Test SystemCHH · Traditional | 02/15/2013SE |
| K120664 | Piccolo Trglycerides-Capillary Test SystemJGY · Traditional | 04/24/2012SE |
| K120662 | Piccolo Hdl-Capillary Test SystemJHM · Traditional | 04/24/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | 01/15/2010SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | 10/01/2009SE |
| K051108 | Piccolo Lactate Dephydrogenase Test SystemCFJ · Traditional | 07/08/2005SE |
| K040115 | Piccolo Magnesium Test SystemJGJ · Traditional | 01/30/2004SE |
| K023642 | Piccolo Total Cholesterol Test SystemCHH · Traditional | 01/24/2003SE |
Questions and answers
When was Epoc 2000 Point-Of-Care Analyzer and Epoc 5-CHEMISTRY Reagent Rotor cleared by the FDA?
Epoc 2000 Point-Of-Care Analyzer and Epoc 5-CHEMISTRY Reagent Rotor (K934592) received a 510(k) decision of Substantially Equivalent on April 6, 1994, 194 days after the submission was received.
What is the product code of K934592?
The FDA product code is JJG – Analyzer, Chemistry, Centrifugal, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2140.