Light Diagnostics Pneumocystis Carinii Dfa, Model 31965
FDA 510(k) K992252 · Chemicon Intl., Inc.
510(k) numberK992252
Submission
- Device name
- Light Diagnostics Pneumocystis Carinii Dfa, Model 31965
- Applicant
- Chemicon Intl., Inc.
Temecula, CA, US - Received
- July 6, 1999
- Decision date
- August 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K923349 | Fungi Fluor KitLYF · Traditional | Polysciences, Inc. | 10/20/1992SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K940473 | Enterovirus 71 Monoclonal AntibodyGOE · Traditional | 09/12/1995SE |
| K940027 | Enterovirus Blend Monoclonal AntibodiesGOE · Traditional | 09/12/1995SE |
| K940472 | Coxsackievirus B5 Monoclonal AntibodyGNM · Traditional | 09/08/1995SE |
| K940471 | Coxsackievirus B Blend Monoclonal AntibodiesGNM · Traditional | 09/08/1995SE |
| K936145 | Coxsackievirus B1 Monoclonal AntibodyGNM · Traditional | 09/08/1995SE |
| K936089 | Coxsackie A24 Virus Monoclonal AntibodyGNM · Traditional | 09/08/1995SE |
| K936073 | Enterovirus Monocl Antibody Det of Coxsackie A9 VirusGNM · Traditional | 09/08/1995SE |
Questions and answers
When was Light Diagnostics Pneumocystis Carinii Dfa, Model 31965 cleared by the FDA?
Light Diagnostics Pneumocystis Carinii Dfa, Model 31965 (K992252) received a 510(k) decision of Substantially Equivalent on August 10, 1999, 35 days after the submission was received.
What is the product code of K992252?
The FDA product code is LYF – Pneumocystis Carinii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.