JJI · Analyzer, Enzyme, For Clinical Use
Clinical Chemistry · 21 CFR 862.2500 · Class 1
Overview
| Product Code | JJI |
|---|---|
| Device Name | Analyzer, Enzyme, For Clinical Use |
| Regulation | 21 CFR 862.2500 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An enzyme analyzer for clinical use is a device intended to measure enzymes in plasma or serum by nonkinetic or kinetic measurement of enzyme-catalyzed reactions. This device is used in conjunction with certain materials to measure a variety of enzymes as an aid in the diagnosis and treatment of certain enzyme-related disorders.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972024 | CODA AUTOMATED EIA ANALYZER | Bio-Rad | Jul 30, 1997 | SESE |
| K944731 | ABBOTT IMX 2 ANALYZER | Abbott Laboratories | Dec 19, 1994 | SESE |
| K931970 | ABBOTT IMX2 ANALYER | Abbott Laboratories | Jun 16, 1993 | SESE |
| K930898 | RADIAS AUTOMATED IMMUNOASSAY SYSTEM | Bio-Rad | Apr 21, 1993 | SESE |
| K790073 | ANALYZER, IMPACT 100 | Gilford Instrument Laboratories, Inc. | Feb 22, 1979 | SESE |
| K780972 | QUICKRATE REACTION RATE ANALYZER | Olympus Corp. | Aug 14, 1978 | SESE |
| K771591 | MINISTAT-S CHEMISTRY ANALYZER | Biokinetix Corp. | Sep 20, 1977 | SESE |
| K770401 | LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 26, 1977 | SESE |
Top Applicants
- Abbott Laboratories — 2 clearances
- Bio-Rad — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biokinetix Corp. — 1 clearance
- Gilford Instrument Laboratories, Inc. — 1 clearance
