FDA product code JJC: Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
JJC is the FDA product code for analyzer, chemistry (sequential multiple, continuous flow) clinical use. It is a Class I device, regulated under 21 CFR 862.2150 and reviewed by the Clinical Chemistry panel. FDA has cleared 32 510(k) submissions under JJC, from 20 different applicants. The average 510(k) review took 63 days (median 58). FDA has posted 1 recall for JJC devices.
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2150 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJC clearance
Top JJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Technicon Instruments Corp. | 12 | 1990-07-17 |
| Gilford Instrument Laboratories, Inc. | 2 | 1982-11-29 |
| Avl Scientific Corp. | 1 | 1995-04-05 |
| Nova Biomedical Corp. | 1 | 1995-02-08 |
| Miles, Inc. | 1 | 1994-09-14 |
15 more applicants have JJC clearances. See the full list in Caduvo.
Most recent JJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945915 | Avl Scientific Corp. | AVL OMNI ANALYZER | 1995-04-05 | 124 |
| K945584 | Nova Biomedical Corp. | NOVA 16 ANALYZER | 1995-02-08 | 86 |
| K943376 | Miles, Inc. | OPERA SYSTEM | 1994-09-14 | 63 |
| K901410 | Technicon Instruments Corp. | TECHNICON RA-2000(TM) SYSTEM | 1990-07-17 | 113 |
| K901141 | Baxter Healthcare Corp | PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX | 1990-04-09 | 27 |
Recalls for JJC devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-08-24.
Frequently asked questions
What is FDA product code JJC?
JJC is the FDA product code for analyzer, chemistry (sequential multiple, continuous flow) clinical use. It is a Class I device, regulated under 21 CFR 862.2150 and reviewed by the Clinical Chemistry panel.
What device class is JJC?
Class I, regulation 21 CFR 862.2150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJC?
Across 32 cleared submissions the average was 63 days from receipt to decision (median 58).
Which companies have the most JJC clearances?
Technicon Instruments Corp. (12); Gilford Instrument Laboratories, Inc. (2); Avl Scientific Corp. (1); Nova Biomedical Corp. (1); Miles, Inc. (1).
Have JJC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-08-24.
Next steps
- Run an FDA pathway report with predicate devices for product code JJC
- Run a recall and safety report across every JJC manufacturer
- Watch product code JJC 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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