Cobas Fara II Centrifugal Analyzer
FDA 510(k) K893854 · Roche Diagnostic Systems, Inc.
510(k) numberK893854
Submission
- Device name
- Cobas Fara II Centrifugal Analyzer
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- May 25, 1989
- Decision date
- August 3, 1989
- 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Cobas Fara II Centrifugal Analyzer cleared by the FDA?
Cobas Fara II Centrifugal Analyzer (K893854) received a 510(k) decision of Substantially Equivalent on August 3, 1989, 70 days after the submission was received.
What is the product code of K893854?
The FDA product code is JJG – Analyzer, Chemistry, Centrifugal, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2140.