PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
FDA 510(k) clearance K890768 · decided 1989-03-21
Clearance details
- K-number
- K890768
- Device name
- PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
- Applicant
- Genetic Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-02-15
- Decision date
- 1989-03-21
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- LYF
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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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 |
| MERIFLUOR TM PNEUMOCYSTIS MODIFICATION (K904400) | Meridian Diagnostics, Inc. | 1990-10-16 |
| 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.