MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
FDA 510(k) clearance K904400 · decided 1990-10-16
Clearance details
- K-number
- K904400
- Device name
- MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-21
- Decision date
- 1990-10-16
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- LYF
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Meridian Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.