FDA product code JJG: Analyzer, Chemistry, Centrifugal, For Clinical Use
JJG is the FDA product code for analyzer, chemistry, centrifugal, for clinical use. It is a Class I device, regulated under 21 CFR 862.2140 and reviewed by the Clinical Chemistry panel. FDA has cleared 30 510(k) submissions under JJG, from 19 different applicants. The average 510(k) review took 59 days (median 46). FDA has posted 1 recall for JJG devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Chemistry, Centrifugal, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2140 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJG clearance
Top JJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 4 | 1991-02-27 |
| Union Carbide Corp. | 4 | 1980-06-09 |
| Abaxis, Inc. | 2 | 1995-03-13 |
| Beckman Instruments, Inc. | 2 | 1990-10-15 |
| Instrumentation Laboratory CO | 2 | 1987-06-11 |
14 more applicants have JJG clearances. See the full list in Caduvo.
Most recent JJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972409 | Landmark Scientific, Inc. | AG CHEMISTRY ANALYZER SYSTEM | 1997-08-28 | 63 |
| K942782 | Abaxis, Inc. | PICCOLO(TM) | 1995-03-13 | 273 |
| K934592 | Abaxis, Inc. | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | 1994-04-06 | 194 |
| K920942 | Olympus Corp. | OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER | 1992-06-10 | 104 |
| K910222 | Roche Diagnostic Systems, Inc. | COBAS ALPHA | 1991-02-27 | 40 |
Recalls for JJG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-12-11.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code JJG?
JJG is the FDA product code for analyzer, chemistry, centrifugal, for clinical use. It is a Class I device, regulated under 21 CFR 862.2140 and reviewed by the Clinical Chemistry panel.
What device class is JJG?
Class I, regulation 21 CFR 862.2140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJG?
Across 30 cleared submissions the average was 59 days from receipt to decision (median 46).
Which companies have the most JJG clearances?
Roche Diagnostic Systems, Inc. (4); Union Carbide Corp. (4); Abaxis, Inc. (2); Beckman Instruments, Inc. (2); Instrumentation Laboratory CO (2).
Have JJG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code JJG
- Run a recall and safety report across every JJG manufacturer
- Watch product code JJG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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