Staining System for Pneumocystis Carinii
FDA 510(k) K905504 · Dako Corp.
510(k) numberK905504
Submission
- Device name
- Staining System for Pneumocystis Carinii
- Applicant
- Dako Corp.
Carpinteria, CA, US - Received
- December 7, 1990
- Decision date
- June 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYF – Pneumocystis Carinii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K992252 | Light Diagnostics Pneumocystis Carinii Dfa, Model 31965LYF · Special | Chemicon Intl., Inc. | 08/10/1999SE |
| K923349 | Fungi Fluor KitLYF · Traditional | Polysciences, Inc. | 10/20/1992SE |
| K904400 | Merifluor TM Pneumocystis ModificationLYF · Traditional | Meridian Diagnostics, Inc. | 10/16/1990SE |
| K890768 | Pneumocystis Carinii Immunofluorescence Test KitLYF · Traditional | Genetic Systems Corp. | 03/21/1989SE |
| K884047 | Fluoroslide Pneumocystis Carinii (Ifa) AssayLYF · Traditional | Disease Detection International, Inc. | 03/14/1989SE |
| K881608 | Merifluor(Tm) PneumocystisLYF · Traditional | Meridian Diagnostics, Inc. | 08/04/1988SE |
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|---|---|---|
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| K991454 | Mouse IGG1 Negative ControlsGKZ · Traditional | 06/21/1999SE |
| K991402 | Dako Mouse Anti-Human T-Cell, CD3/RPE-CY5, Clone UCHT1 & Dako Mouse Anti-Human T-Cell…GKZ · Traditional | 06/21/1999SE |
| K980635 | Dako Mouse Anti-Human B-Cell, CD19/RPE-CY5, Clone HD37GKZ · Traditional | 07/22/1998SE |
| K971905 | Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…DEH · Traditional | 12/12/1997SE |
| K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, BER-H2 Antibody for Immunoenzymatic…DEH · Traditional | 11/06/1997SE |
| K964974 | Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/RpeGKZ · Traditional | 06/24/1997SE |
| K961701 | Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) RpeGKZ · Traditional | 07/16/1996SE |
| K951965 | Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDEH · Traditional | 07/05/1996SE |
Questions and answers
When was Staining System for Pneumocystis Carinii cleared by the FDA?
Staining System for Pneumocystis Carinii (K905504) received a 510(k) decision of Substantially Equivalent on June 28, 1991, 203 days after the submission was received.
What is the product code of K905504?
The FDA product code is LYF – Pneumocystis Carinii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.