FDA product code JTR: Kit, Quality Control For Culture Media
JTR is the FDA product code for kit, quality control for culture media. It is a Class I device, regulated under 21 CFR 866.2480 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under JTR, from 10 different applicants. The average 510(k) review took 30 days (median 25). FDA has posted 46 recalls for JTR devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Quality Control For Culture Media |
| Device class | Class I |
| Regulation | 21 CFR 866.2480 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JTR clearance
Top JTR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micro-Bio-Logics | 3 | 1986-04-04 |
| Pro-Lab, Inc. | 1 | 1987-04-14 |
| Trend Scientific, Inc. | 1 | 1986-09-16 |
| Biological & Environmental Control Laboratories | 1 | 1984-07-27 |
| Austin Biological Laboratories | 1 | 1983-07-28 |
5 more applicants have JTR clearances. See the full list in Caduvo.
Most recent JTR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871121 | Pro-Lab, Inc. | PROTECT T.M. | 1987-04-14 | 26 |
| K862914 | Trend Scientific, Inc. | FEKAL CHECK PARASITOLOGY CONTROL SLIDE | 1986-09-16 | 46 |
| K861022 | Micro-Bio-Logics | KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS | 1986-04-04 | 17 |
| K855198 | Micro-Bio-Logics | INDI KWIK (TM) CO/TWO KIT | 1986-01-14 | 18 |
| K842579 | Biological & Environmental Control Laboratories | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS | 1984-07-27 | 24 |
Recalls for JTR devices
46 product recalls in 27 recall events; 13 initiated in the last five years and 12 still open. Most recent: 2025-12-02.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 17 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 8 |
Frequently asked questions
What is FDA product code JTR?
JTR is the FDA product code for kit, quality control for culture media. It is a Class I device, regulated under 21 CFR 866.2480 and reviewed by the Microbiology panel.
What device class is JTR?
Class I, regulation 21 CFR 866.2480. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTR?
Across 12 cleared submissions the average was 30 days from receipt to decision (median 25).
Which companies have the most JTR clearances?
Micro-Bio-Logics (3); Pro-Lab, Inc. (1); Trend Scientific, Inc. (1); Biological & Environmental Control Laboratories (1); Austin Biological Laboratories (1).
Have JTR devices been recalled?
Yes: 46 product recalls across 27 recall events; the most recent began 2025-12-02.
Next steps
- Run an FDA pathway report with predicate devices for product code JTR
- Run a recall and safety report across every JTR manufacturer
- Watch product code JTR 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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