LYF — Pneumocystis Carinii Class II
FDA product code LYF covers "Pneumocystis Carinii", a Class II medical device regulated under 21 CFR 866.3780. Submissions are reviewed by the Microbiology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYF
- Device Class
- Class II
- Regulation Number
- 866.3780
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K992252 | chemicon intl | LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 | August 10, 1999 |
| K923349 | polysciences | FUNGI FLUOR KIT | October 20, 1992 |
| K905504 | dako | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII | June 28, 1991 |
| K904400 | meridian diagnostics | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION | October 16, 1990 |
| K890768 | genetic systems | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | March 21, 1989 |
| K884047 | disease detection international | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY | March 14, 1989 |
| K881608 | meridian diagnostics | MERIFLUOR(TM) PNEUMOCYSTIS | August 4, 1988 |