510(k) K992252
- Device
- LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
- Applicant
- CHEMICON INTL., INC.
- 510(k) number
- K992252
- Product code
- LYF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-10
- Date received
- 1999-07-06
- Regulation
- 866.3780
- Classification name
- Pneumocystis Carinii
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CINDY PENNY
- Address
- 28835 Single Oak Dr. Temecula CA US 92590 92590
FDA Registration Numbers#
- 1524213
- 3032705
- 2915274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LYF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923349 | FUNGI FLUOR KIT | Polysciences, Inc. | 1992-10-20 |
| K905504 | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII | Dako Corp. | 1991-06-28 |
| K904400 | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION | Meridian Diagnostics, Inc. | 1990-10-16 |
| K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | Genetic Systems Corp. | 1989-03-21 |
| K884047 | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY | Disease Detection International, Inc. | 1989-03-14 |
| K881608 | MERIFLUOR(TM) PNEUMOCYSTIS | Meridian Diagnostics, Inc. | 1988-08-04 |
Legacy Summary#
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FDA Review#
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