Leeco Preview(R) Ebv (Eia)
FDA 510(k) K895765 · Leeco Diagnostics, Inc.
510(k) numberK895765
Submission
- Device name
- Leeco Preview(R) Ebv (Eia)
- Applicant
- Leeco Diagnostics, Inc.
Southfield, MI, US - Received
- September 26, 1989
- Decision date
- October 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTN – System, Test, Infectious Mononucleosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5640
- Specialty
- Immunology
Other 510(k)s with product code KTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…KTN · Special | SEKISUI Diagnostics, LLC | 06/22/2018SE |
| K042272 | Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)KTN · Traditional | ACON Laboratories, Inc. | 02/28/2005SE |
| K030215 | Biorapid MononucleosisKTN · Traditional | Instrumentation Laboratory CO | 02/24/2003SE |
| K012901 | Color-MonogenKTN · Traditional | Instrumentation Laboratory CO | 09/27/2001SE |
| K982634 | Dryspot Infectious Mononucleosis KitKTN · Traditional | Oxoid , Ltd. | 01/28/1999SE |
| K981946 | Clearview ImKTN · Traditional | Unipath , Ltd. | 12/10/1998SE |
| K972457 | Monocol/Lex-Im TestKTN · Traditional | Immunostics Inc., | 12/01/1997SE |
| K972231 | Osom Mono Test 143KTN · Traditional | Wyntek Diagnostics, Inc. | 08/26/1997SE |
| K963425 | Genzyme Diagnostics Contrast MonoKTN · Traditional | Genzyme Diagnostics | 02/25/1997SE |
| K961024 | Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WBKTN · Traditional | Princeton BioMeditech Corp. | 02/04/1997SE |
More from Princeton BioMeditech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K894122 | Leeco Vis-Disk Strep-A (Eia)GTZ · Traditional | 08/15/1989SE |
| K891096 | Vis-Disk HCG (Eia) JPL-041MDHA · Traditional | 06/16/1989SE |
| K891095 | Vis-Disk HCG (Eia) Lyophilized JPL-044MDHA · Traditional | 06/16/1989SE |
| K883269 | Prl-QuantCFT · Traditional | 09/13/1988SE |
| K880577 | CONCEP-7-BHCGJHI · Traditional | 03/15/1988SE |
| K880069 | Leeco Pregnastick (Eia) Catalog #003LCX · Traditional | 02/11/1988SE |
| K870259 | Vis-Cube HCG (Eia) Lyophilized JPL-044JHI · Traditional | 03/10/1987SE |
| K864170 | Leeco Vis-Cube Strep a (Eia)GTZ · Traditional | 02/03/1987SE |
| K863999 | Vis-Cube Pregnancy Home Test,Cat. # JPL-042LCX · Traditional | 01/09/1987SE |
| K863933 | Vis-Cube HCG (Eia)JHI · Traditional | 12/15/1986SE |
Questions and answers
When was Leeco Preview(R) Ebv (Eia) cleared by the FDA?
Leeco Preview(R) Ebv (Eia) (K895765) received a 510(k) decision of Substantially Equivalent on October 31, 1989, 35 days after the submission was received.
What is the product code of K895765?
The FDA product code is KTN – System, Test, Infectious Mononucleosis, a Class II (moderate risk) device regulated under 21 CFR 866.5640.