Fluoroslide Pneumocystis Carinii (Ifa) Assay
FDA 510(k) K884047 · Disease Detection International, Inc.
510(k) numberK884047
Submission
- Device name
- Fluoroslide Pneumocystis Carinii (Ifa) Assay
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- September 26, 1988
- Decision date
- March 14, 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 |
| K890768 | Pneumocystis Carinii Immunofluorescence Test KitLYF · Traditional | Genetic Systems Corp. | 03/21/1989SE |
| K881608 | Merifluor(Tm) PneumocystisLYF · Traditional | Meridian Diagnostics, Inc. | 08/04/1988SE |
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| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | 11/29/1989SE |
| K884249 | Modified Ddi Serocard Toxoplasma Igg Test KitLGD · Traditional | 04/10/1989SE |
| K884248 | Modified Ddi Serocard CMV Igg Test KitLFZ · Traditional | 04/10/1989SE |
Questions and answers
When was Fluoroslide Pneumocystis Carinii (Ifa) Assay cleared by the FDA?
Fluoroslide Pneumocystis Carinii (Ifa) Assay (K884047) received a 510(k) decision of Substantially Equivalent on March 14, 1989, 169 days after the submission was received.
What is the product code of K884047?
The FDA product code is LYF – Pneumocystis Carinii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.