FDA product code JTY: Culture Media, For Isolation Of Pathogenic Neisseria
JTY is the FDA product code for culture media, for isolation of pathogenic neisseria. It is a Class II device, regulated under 21 CFR 866.2410 and reviewed by the Microbiology panel. FDA has cleared 83 510(k) submissions under JTY, from 43 different applicants. The average 510(k) review took 44 days (median 28). FDA has posted 9 recalls for JTY devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, For Isolation Of Pathogenic Neisseria |
| Device class | Class II |
| Regulation | 21 CFR 866.2410 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JTY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 239 |
Compare with all 510(k) review times · Search every JTY clearance
Top JTY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Granite Diagnostics, Inc. | 6 | 1977-10-25 |
| Gibco Laboratories Life Technologies, Inc. | 5 | 1987-04-29 |
| Otisville Biotech, Inc. | 5 | 1986-02-24 |
| Isle Media and Sterile Products, Inc. | 5 | 1980-03-03 |
| Flow Laboratories, Inc. | 4 | 1976-10-07 |
38 more applicants have JTY clearances. See the full list in Caduvo.
Most recent JTY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210511 | Biomed Diagnostics Incorporated | InTray GC | 2021-10-20 | 239 |
| K993033 | Biomed Diagnostics, Inc. | INTRAY GC | 1999-12-16 | 98 |
| K954986 | Remel, L.P. | GC BASE W/ 1% GCHI | 1996-02-16 | 108 |
| K950196 | Bioclinical Systems, Inc. | CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA | 1995-06-30 | 163 |
| K933122 | Bioclinical Systems, Inc. | MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR | 1994-02-09 | 229 |
Recalls for JTY devices
9 product recalls in 8 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-06-03.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code JTY?
JTY is the FDA product code for culture media, for isolation of pathogenic neisseria. It is a Class II device, regulated under 21 CFR 866.2410 and reviewed by the Microbiology panel.
What device class is JTY?
Class II, regulation 21 CFR 866.2410. Typical premarket route: 510(k).
How long does a 510(k) take for product code JTY?
Across 83 cleared submissions the average was 44 days from receipt to decision (median 28).
Which companies have the most JTY clearances?
Granite Diagnostics, Inc. (6); Gibco Laboratories Life Technologies, Inc. (5); Otisville Biotech, Inc. (5); Isle Media and Sterile Products, Inc. (5); Flow Laboratories, Inc. (4).
Have JTY devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2026-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JTY
- Run a recall and safety report across every JTY manufacturer
- Watch product code JTY 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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