FDA product code JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
JSO is the FDA product code for culture media, antimicrobial susceptibility test, excluding mueller hinton agar. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel. FDA has cleared 40 510(k) submissions under JSO, from 18 different applicants. The average 510(k) review took 152 days (median 110). FDA has posted 56 recalls for JSO devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Device class | Class II |
| Regulation | 21 CFR 866.1700 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JSO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 242 |
| 2018 | 1 | 72 |
| 2019 | 1 | 55 |
Compare with all 510(k) review times · Search every JSO clearance
Top JSO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 6 | 2017-12-28 |
| Hardy Diagnostics | 5 | 2019-04-29 |
| bioMerieux, Inc. | 4 | 2016-10-25 |
| Becton Dickinson Microbiology Systems | 3 | 1995-02-02 |
| Remel Co. | 3 | 1994-09-19 |
13 more applicants have JSO clearances. See the full list in Caduvo.
Most recent JSO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190553 | Hardy Diagnostics | HardyCHROM CRE | 2019-04-29 | 55 |
| K181092 | Biomerieux S.A. | CHROMID CARBA agar (CARB) | 2018-07-06 | 72 |
| K171061 | Bio-Rad | MRSASelect II | 2017-12-28 | 262 |
| K162620 | Remel, Inc. | Remel Spectra ESBL | 2017-05-01 | 223 |
| K160512 | Hardy Diagnostics | HardyCHROM ESBL | 2016-11-15 | 265 |
Recalls for JSO devices
56 product recalls in 21 recall events; 17 initiated in the last five years and 19 still open. Most recent: 2025-05-06.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 3 |
| 2022 | 15 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JSO?
JSO is the FDA product code for culture media, antimicrobial susceptibility test, excluding mueller hinton agar. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel.
What device class is JSO?
Class II, regulation 21 CFR 866.1700. Typical premarket route: 510(k).
How long does a 510(k) take for product code JSO?
Across 40 cleared submissions the average was 152 days from receipt to decision (median 110).
Which companies have the most JSO clearances?
Bio-Rad (6); Hardy Diagnostics (5); bioMerieux, Inc. (4); Becton Dickinson Microbiology Systems (3); Remel Co. (3).
Have JSO devices been recalled?
Yes: 56 product recalls across 21 recall events; the most recent began 2025-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code JSO
- Run a recall and safety report across every JSO manufacturer
- Watch product code JSO 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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