Merifluor TM Pneumocystis Modification
FDA 510(k) K904400 · Meridian Diagnostics, Inc.
510(k) numberK904400
Submission
- Device name
- Merifluor TM Pneumocystis Modification
- Applicant
- Meridian Diagnostics, Inc.
Cincinnati, OH, US - Received
- September 21, 1990
- Decision date
- October 16, 1990
- 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 |
| K905504 | Staining System for Pneumocystis CariniiLYF · Traditional | Dako Corp. | 06/28/1991SE |
| 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 |
More from Meridian Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993914 | Premier Toxins A&B, Model 616096LLH · Special | 12/10/1999SE |
| K990263 | Immunocard Stat! E. Coli O157:H7GMZ · Traditional | 08/09/1999SE |
| K984346 | Premier Type Specific HSV-2 Igg Elisa TestLGC · Traditional | 06/25/1999SE |
| K984343 | Premier Type Specific HSV-1 Igg Elisa TestMXJ · Traditional | 06/25/1999SE |
| K983255 | Modification to: Premier Platinum HpsaLYR · Traditional | 12/17/1998SE |
| K982764 | Premier CryptosporidiumMHJ · Traditional | 12/03/1998SE |
| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | 08/20/1997SE |
Questions and answers
When was Merifluor TM Pneumocystis Modification cleared by the FDA?
Merifluor TM Pneumocystis Modification (K904400) received a 510(k) decision of Substantially Equivalent on October 16, 1990, 25 days after the submission was received.
What is the product code of K904400?
The FDA product code is LYF – Pneumocystis Carinii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.