Ministat-S Chemistry Analyzer
FDA 510(k) K771591 · Biokinetix Corp.
510(k) numberK771591
Submission
- Device name
- Ministat-S Chemistry Analyzer
- Applicant
- Biokinetix Corp.
Mchenry, IL, US - Received
- August 19, 1977
- Decision date
- September 20, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K930898 | Radias Automated Immunoassay SystemJJI · Traditional | Bio-Rad | 04/21/1993SE |
| K790073 | Analyzer, Impact 100JJI · Traditional | Gilford Instrument Laboratories, Inc. | 02/22/1979SE |
| K780972 | Quickrate Reaction Rate AnalyzerJJI · Traditional | Olympus Corp. | 08/14/1978SE |
| K770401 | Ldh/Nadh,Ldh/Nadh, Nad & Nad DiaphoraseJJI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/26/1977SE |
Questions and answers
When was Ministat-S Chemistry Analyzer cleared by the FDA?
Ministat-S Chemistry Analyzer (K771591) received a 510(k) decision of Substantially Equivalent on September 20, 1977, 32 days after the submission was received.
What is the product code of K771591?
The FDA product code is JJI – Analyzer, Enzyme, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2500.