FDA product code JXC: Kit, Screening, Yeast
JXC is the FDA product code for kit, screening, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under JXC, from 6 different applicants. The average 510(k) review took 134 days (median 136).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Screening, Yeast |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JXC clearance
Top JXC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hardy Diagnostics | 1 | 1996-08-02 |
| Jrga Diagnostics | 1 | 1992-04-22 |
| Remel Co. | 1 | 1989-06-02 |
| Carr-Scarborough Microbiologicals, Inc. | 1 | 1989-04-12 |
| The Cancer Center AT Wadley Institutes | 1 | 1988-07-18 |
1 more applicants have JXC clearances. See the full list in Caduvo.
Most recent JXC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960075 | Hardy Diagnostics | CHROMAGAR CANDIDA | 1996-08-02 | 204 |
| K913426 | Jrga Diagnostics | ALBICANS SURE | 1992-04-22 | 265 |
| K884720 | Remel Co. | GERM TUBE SOLUTION | 1989-06-02 | 204 |
| K891476 | Carr-Scarborough Microbiologicals, Inc. | C. ALBICANS SCREEN | 1989-04-12 | 27 |
| K882371 | The Cancer Center AT Wadley Institutes | SOC SLIDE CULTURE SYSTEM | 1988-07-18 | 40 |
Recalls for JXC devices
openFDA lists no recalls for product code JXC.
Frequently asked questions
What is FDA product code JXC?
JXC is the FDA product code for kit, screening, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is JXC?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JXC?
Across 6 cleared submissions the average was 134 days from receipt to decision (median 136).
Which companies have the most JXC clearances?
Hardy Diagnostics (1); Jrga Diagnostics (1); Remel Co. (1); Carr-Scarborough Microbiologicals, Inc. (1); The Cancer Center AT Wadley Institutes (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JXC
- Run a recall and safety report across every JXC manufacturer
- Watch product code JXC 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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