AG Chemistry Analyzer System
FDA 510(k) K972409 · Landmark Scientific, Inc.
510(k) numberK972409
Submission
- Device name
- AG Chemistry Analyzer System
- Applicant
- Landmark Scientific, Inc.
Rockville, MD, US - Received
- June 26, 1997
- Decision date
- August 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K871838 | Biomek 1000C Automated Laboratory Work StationJJG · Traditional | Beckman Instruments, Inc. | 05/26/1987SE |
Questions and answers
When was AG Chemistry Analyzer System cleared by the FDA?
AG Chemistry Analyzer System (K972409) received a 510(k) decision of Substantially Equivalent on August 28, 1997, 63 days after the submission was received.
What is the product code of K972409?
The FDA product code is JJG – Analyzer, Chemistry, Centrifugal, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2140.