FDA product code JTZ: Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
JTZ is the FDA product code for culture media, antimicrobial susceptibility test, mueller hinton agar/broth. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel. FDA has cleared 75 510(k) submissions under JTZ, 1 in the last five years, from 47 different applicants. The average 510(k) review took 50 days (median 28); 80 days on average over the last three years. FDA has posted 8 recalls for JTZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth |
| 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 JTZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 80 |
Compare with all 510(k) review times · Search every JTZ clearance
Top JTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hardy Media | 5 | 1988-03-30 |
| Biomedia, Inc. | 5 | 1981-06-18 |
| Mds Laboratories, Inc. | 4 | 1987-03-31 |
| Gibco Laboratories Life Technologies, Inc. | 3 | 1986-10-09 |
| Interstate Media | 3 | 1982-06-01 |
42 more applicants have JTZ clearances. See the full list in Caduvo.
Most recent JTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262163 | Becton Dickinson and Company | BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth | 2026-09-14 | 80 |
| K132491 | Edge Biologicals, Inc. | MUELLER HINTON AGAR | 2014-06-30 | 326 |
| K963036 | Becton Dickinson Microbiology Systems | MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD | 1996-10-07 | 63 |
| K960420 | Becton Dickinson Microbiology Systems | MUELLER HINTON AGAR WITH 5% SHEEP BLOOD | 1996-04-04 | 66 |
| K960313 | Remel, L.P. | MUELLER HINTON AGAR WITH 2% NACI | 1996-03-25 | 63 |
Recalls for JTZ devices
8 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JTZ?
JTZ is the FDA product code for culture media, antimicrobial susceptibility test, mueller hinton agar/broth. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel.
What device class is JTZ?
Class II, regulation 21 CFR 866.1700. Typical premarket route: 510(k).
How long does a 510(k) take for product code JTZ?
Across 75 cleared submissions the average was 50 days from receipt to decision (median 28).
Which companies have the most JTZ clearances?
Hardy Media (5); Biomedia, Inc. (5); Mds Laboratories, Inc. (4); Gibco Laboratories Life Technologies, Inc. (3); Interstate Media (3).
Have JTZ devices been recalled?
Yes: 8 product recalls across 8 recall events; the most recent began 2025-11-12.
Next steps
- Run an FDA pathway report with predicate devices for product code JTZ
- Run a recall and safety report across every JTZ manufacturer
- Watch product code JTZ 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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