Analyzer, Enzyme, For Clinical Use
This device is an automated enzyme analyzer designed for clinical use to measure the activity of specific enzymes in patient specimens, providing data used in diagnosing conditions such as liver disease, myocardial infarction, and other enzymatic disorders. It is classified as FDA Class 1, subject only to general regulatory controls with no premarket submission required. The product code is JJI, regulated under 21 CFR 862.2500, and falls within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JJI
- Device Class
- FDA class 1
- Regulation Number
- 862.2500
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972024 | CODA AUTOMATED EIA ANALYZER | Jul 30, 1997 | Substantially Equivalent | Bio-Rad |
| K944731 | ABBOTT IMX 2 ANALYZER | Dec 19, 1994 | Substantially Equivalent | Abbott Laboratories |
| K931970 | ABBOTT IMX2 ANALYER | Jun 16, 1993 | Substantially Equivalent | Abbott Laboratories |
| K930898 | RADIAS AUTOMATED IMMUNOASSAY SYSTEM | Apr 21, 1993 | Substantially Equivalent | Bio-Rad |
| K790073 | ANALYZER, IMPACT 100 | Feb 22, 1979 | Substantially Equivalent | Gilford Instrument Laboratories, Inc. |
| K780972 | QUICKRATE REACTION RATE ANALYZER | Aug 14, 1978 | Substantially Equivalent | Olympus Corp. |
| K771591 | MINISTAT-S CHEMISTRY ANALYZER | Sep 20, 1977 | Substantially Equivalent | Biokinetix Corp. |
| K770401 | LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE | Apr 26, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.