FDA product code JTL: Plasma, Coagulase, Human, Horse And Rabbit
JTL is the FDA product code for plasma, coagulase, human, horse and rabbit. It is a Class I device, regulated under 21 CFR 866.2160 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under JTL, from 10 different applicants. The average 510(k) review took 36 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Plasma, Coagulase, Human, Horse And Rabbit |
| Device class | Class I |
| Regulation | 21 CFR 866.2160 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JTL clearance
Top JTL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 2 | 1984-04-13 |
| Analytical Products, Inc. | 2 | 1983-12-22 |
| Difco Laboratories, Inc. | 1 | 1995-05-16 |
| Immuno-Mycologics, Inc. | 1 | 1988-08-25 |
| Oxoid U.S.A., Inc. | 1 | 1987-06-10 |
5 more applicants have JTL clearances. See the full list in Caduvo.
Most recent JTL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950706 | Difco Laboratories, Inc. | DRYSLIDE COAGULASE | 1995-05-16 | 90 |
| K883333 | Immuno-Mycologics, Inc. | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | 1988-08-25 | 16 |
| K870945 | Oxoid U.S.A., Inc. | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | 1987-06-10 | 93 |
| K861312 | Micro-Bio-Logics | LYFO-KWIK (TM) COAGULASE PLASMA | 1986-04-18 | 10 |
| K840553 | Remel Co. | HEMASTAPH | 1984-04-13 | 65 |
Recalls for JTL devices
openFDA lists no recalls for product code JTL.
Frequently asked questions
What is FDA product code JTL?
JTL is the FDA product code for plasma, coagulase, human, horse and rabbit. It is a Class I device, regulated under 21 CFR 866.2160 and reviewed by the Microbiology panel.
What device class is JTL?
Class I, regulation 21 CFR 866.2160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JTL?
Across 12 cleared submissions the average was 36 days from receipt to decision (median 28).
Which companies have the most JTL clearances?
Remel Co. (2); Analytical Products, Inc. (2); Difco Laboratories, Inc. (1); Immuno-Mycologics, Inc. (1); Oxoid U.S.A., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JTL
- Run a recall and safety report across every JTL manufacturer
- Watch product code JTL 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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