Radias Automated Immunoassay System
FDA 510(k) K930898 · Bio-Rad
510(k) numberK930898
Submission
- Device name
- Radias Automated Immunoassay System
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- February 22, 1993
- Decision date
- April 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJI – Analyzer, Enzyme, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2500
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972024 | Coda Automated Eia AnalyzerJJI · Traditional | Bio-Rad | 07/30/1997SE |
| K944731 | Abbott Imx 2 AnalyzerJJI · Traditional | Abbott Laboratories | 12/19/1994SE |
| K931970 | Abbott IMX2 AnalyerJJI · Traditional | Abbott Laboratories | 06/16/1993SE |
| K790073 | Analyzer, Impact 100JJI · Traditional | Gilford Instrument Laboratories, Inc. | 02/22/1979SE |
| K780972 | Quickrate Reaction Rate AnalyzerJJI · Traditional | Olympus Corp. | 08/14/1978SE |
| K771591 | Ministat-S Chemistry AnalyzerJJI · Traditional | Biokinetix Corp. | 09/20/1977SE |
| K770401 | Ldh/Nadh,Ldh/Nadh, Nad & Nad DiaphoraseJJI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/26/1977SE |
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Questions and answers
When was Radias Automated Immunoassay System cleared by the FDA?
Radias Automated Immunoassay System (K930898) received a 510(k) decision of Substantially Equivalent on April 21, 1993, 58 days after the submission was received.
What is the product code of K930898?
The FDA product code is JJI – Analyzer, Enzyme, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2500.