Reagent Cups
FDA 510(k) K831569 · American Scientific Products
510(k) numberK831569
Submission
- Device name
- Reagent Cups
- Applicant
- American Scientific Products
Mchenry, IL, US - Received
- May 16, 1983
- Decision date
- June 30, 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 |
|---|---|---|
| K864824 | Infectious Tissue Kit · Traditional | 12/24/1986SE |
| K844042 | Blood Dilution VialGKL · Traditional | 10/23/1984SE |
| K831634 | Glucose Reagent B6360-11CGA · Traditional | 07/19/1983SE |
| K831626 | Urea Nitrogen-Bun-Reagents B6370-11ACDQ · Traditional | 07/07/1983SE |
| K831625 | Urea Nitrogen-Bun-Reagents B6360-12CDQ · Traditional | 07/07/1983SE |
| K831628 | Creatinine Reagents B6370-13CGX · Traditional | 07/06/1983SE |
| K831627 | Creatinine Reagents B6360-10CGX · Traditional | 07/06/1983SE |
| K831624 | Glucose Reagent KITS-B6370-10ACGA · Traditional | 07/06/1983SE |
| K831571 | RotorJJG · Traditional | 06/30/1983SE |
| K822799 | Streptacoccus Co-Agglutination KitGTP · Traditional | 12/19/1982SE |
Questions and answers
When was Reagent Cups cleared by the FDA?
Reagent Cups (K831569) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 45 days after the submission was received.
What is the product code of K831569?
The FDA product code is JJG – Analyzer, Chemistry, Centrifugal, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2140.