Fungi Fluor Kit
FDA 510(k) K923349 · Polysciences, Inc.
510(k) numberK923349
Submission
- Device name
- Fungi Fluor Kit
- Applicant
- Polysciences, Inc.
Warrington, PA, US - Received
- July 8, 1992
- Decision date
- October 20, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K905504 | Staining System for Pneumocystis CariniiLYF · Traditional | Dako Corp. | 06/28/1991SE |
| 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 |
More from Meridian Diagnostics, Inc.
Questions and answers
When was Fungi Fluor Kit cleared by the FDA?
Fungi Fluor Kit (K923349) received a 510(k) decision of Substantially Equivalent on October 20, 1992, 104 days after the submission was received.
What is the product code of K923349?
The FDA product code is LYF – Pneumocystis Carinii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.