FDA product code LYF: Pneumocystis Carinii
LYF is the FDA product code for pneumocystis carinii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel. FDA has cleared 7 510(k) submissions under LYF, from 6 different applicants. The average 510(k) review took 98 days (median 104).
Classification
| Field | Value |
|---|---|
| Device name | Pneumocystis Carinii |
| Device class | Class II |
| Regulation | 21 CFR 866.3780 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LYF clearance
Top LYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 2 | 1990-10-16 |
| Chemicon Intl., Inc. | 1 | 1999-08-10 |
| Polysciences, Inc. | 1 | 1992-10-20 |
| Dako Corp. | 1 | 1991-06-28 |
| Genetic Systems Corp. | 1 | 1989-03-21 |
1 more applicants have LYF clearances. See the full list in Caduvo.
Most recent LYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992252 | Chemicon Intl., Inc. | LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 | 1999-08-10 | 35 |
| K923349 | Polysciences, Inc. | FUNGI FLUOR KIT | 1992-10-20 | 104 |
| K905504 | Dako Corp. | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII | 1991-06-28 | 203 |
| K904400 | Meridian Diagnostics, Inc. | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION | 1990-10-16 | 25 |
| K890768 | Genetic Systems Corp. | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | 1989-03-21 | 34 |
Recalls for LYF devices
openFDA lists no recalls for product code LYF.
Frequently asked questions
What is FDA product code LYF?
LYF is the FDA product code for pneumocystis carinii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel.
What device class is LYF?
Class II, regulation 21 CFR 866.3780. Typical premarket route: 510(k).
How long does a 510(k) take for product code LYF?
Across 7 cleared submissions the average was 98 days from receipt to decision (median 104).
Which companies have the most LYF clearances?
Meridian Diagnostics, Inc. (2); Chemicon Intl., Inc. (1); Polysciences, Inc. (1); Dako Corp. (1); Genetic Systems Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LYF
- Run a recall and safety report across every LYF manufacturer
- Watch product code LYF 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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