Pneumocystis Carinii Immunofluorescence Test Kit
FDA 510(k) K890768 · Genetic Systems Corp.
510(k) numberK890768
Submission
- Device name
- Pneumocystis Carinii Immunofluorescence Test Kit
- Applicant
- Genetic Systems Corp.
Seattle, WA, US - Received
- February 15, 1989
- Decision date
- March 21, 1989
- 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 |
| K904400 | Merifluor TM Pneumocystis ModificationLYF · Traditional | Meridian Diagnostics, Inc. | 10/16/1990SE |
| 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 |
|---|---|---|
| K891767 | Genetic Systems Microplate ReaderJJQ · Traditional | 07/25/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | 05/01/1989SE |
| K873564 | Genetic Systems RSV Reagent Control SlidesLKT · Traditional | 11/20/1987SE |
| K873542 | Microplate Auto-Washer (Motorized Stage)JTC · Traditional | 09/23/1987SE |
| K870176 | Genetic Systems RSV Immunofluorescence Test KitLKT · Traditional | 07/16/1987SE |
| K870879 | Alanine Transaminase (Alt) Test KitCKA · Traditional | 03/19/1987SE |
| K863566 | GSC 1000JJQ · Traditional | 10/16/1986SE |
| K852237 | Legionella Immunofluorescent Antibody Test KitLHL · Traditional | 08/22/1985SE |
Questions and answers
When was Pneumocystis Carinii Immunofluorescence Test Kit cleared by the FDA?
Pneumocystis Carinii Immunofluorescence Test Kit (K890768) received a 510(k) decision of Substantially Equivalent on March 21, 1989, 34 days after the submission was received.
What is the product code of K890768?
The FDA product code is LYF – Pneumocystis Carinii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.