JJI — Analyzer, Enzyme, For Clinical Use Class I
FDA Device Classification
Classification Details
- Product Code
- JJI
- Device Class
- Class I
- Regulation Number
- 862.2500
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K972024 | bio-rad | CODA AUTOMATED EIA ANALYZER | July 30, 1997 |
| K944731 | abbott laboratories | ABBOTT IMX 2 ANALYZER | December 19, 1994 |
| K931970 | abbott laboratories | ABBOTT IMX2 ANALYER | June 16, 1993 |
| K930898 | bio-rad | RADIAS AUTOMATED IMMUNOASSAY SYSTEM | April 21, 1993 |
| K790073 | gilford instrument laboratories | ANALYZER, IMPACT 100 | February 22, 1979 |
| K780972 | olympus | QUICKRATE REACTION RATE ANALYZER | August 14, 1978 |
| K771591 | biokinetix | MINISTAT-S CHEMISTRY ANALYZER | September 20, 1977 |
| K770401 | bd becton dickinson vacutainer systems preanalytic | LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE | April 26, 1977 |