LYF
7 FDA 510(k) clearances · Product code
104 daysmedian time to decision
203 days90th percentile
7clearances measured
FDA profile
- Official device name
- Pneumocystis Carinii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 (K992252) | Chemicon Intl., Inc. | 1999-08-10 |
| FUNGI FLUOR KIT (K923349) | Polysciences, Inc. | 1992-10-20 |
| STAINING SYSTEM FOR PNEUMOCYSTIS CARINII (K905504) | Dako Corp. | 1991-06-28 |
| MERIFLUOR TM PNEUMOCYSTIS MODIFICATION (K904400) | Meridian Diagnostics, Inc. | 1990-10-16 |
| PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT (K890768) | Genetic Systems Corp. | 1989-03-21 |
| FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY (K884047) | Disease Detection International, Inc. | 1989-03-14 |
| MERIFLUOR(TM) PNEUMOCYSTIS (K881608) | Meridian Diagnostics, Inc. | 1988-08-04 |
Track LYF automatically
Every clearance here is in the API, with alerts when new ones post.